5-year Disease-free Survival Rates Research Articles

Fertility-sparing surgery in children and adolescents with borderline ovarian tumors: a retrospective study

ObjectiveTo describe the characteristics of children and adolescents with borderline ovarian tumors (BOTs) and evaluate the efficacy and safety of fertility-sparing surgery (FSS) in these patients.MethodsPatients with BOTs younger than 20 years who underwent FSS were included in this study.ResultsA total of 34 patients were included, with a median patient age of 17 (range, 3–19) years; 97.1% (33/34) of cases occurred after menarche. Of the patients, 82.4% had mucinous borderline tumors (MBOTs), 14.7% had serous borderline tumors (SBOTs), and 2.9% had seromucinous borderline tumor (SMBOT). The median tumor size was 20.4 (range, 8–40)cm. All patients were at International Federation of Gynecology and Obstetrics stage I and all underwent FSS: cystectomy (unilateral ovarian cystectomy, UC, 14/34, 41.2% and bilateral ovarian cystectomy, BC, 1/34, 2.9%), unilateral salpingo-oophorectomy (USO; 18/34; 52.9%), or USO + contralateral ovarian cystectomy (1/34; 2.9%). The median follow-up time was 65 (range, 10–148) months. Recurrence was experienced by 10 of the 34 patients (29.4%). One patient with SBOT experienced progression to low-grade serous carcinoma after the third relapse. Two patients had a total of four pregnancies, resulting in three live births. The recurrence rate of UC was significantly higher in MBOTs than in USO (p = 0.005). The 5-year disease-free survival rate was 67.1%, and the 5-year overall survival rate was 100%.ConclusionsFertility-sparing surgery is feasible and safe for children and adolescents with BOTs. For patients with MBOTs, USO is recommended to lower the risk of recurrence.

Abstract PO1-17-01: Surgical Margins and prognosis of borderline and malignant phyllodes tumors of breast

Abstract Background. To determine the appropriate surgical margin and identify predictive factors for recurrence and prognosis of borderline and malignant phyllodes tumor (PT) of the breast. Methods. A retrospective review of patients with borderline and malignant PT treated from March 2011 to December 2022 at the First Affiliated Hospital of Chongqing Medical University were conducted. The main endpoints of this research were local recurrence-free survival (LRFS) and disease-free survival (DFS). Univariate and multivariate Cox proportional hazard models were used to examine the impacts of different variables on LRFS and DFS, and to calculate hazard ratios (HR) and 95% confidence intervals (CI). Results. Of 155 patients with phyllodes tumors, 87 (56.1%) were classified as borderline while 68 (43.9%) were malignant. All patients included underwent operation, with a median age of 47 years (range,12-66 years) and a median tumor size of 60 mm (range,15-300 mm). Initial surgical margins < 1cm in 72 (46.5%) patients, of which 28 (38.9%) underwent reoperation, resulting in 45 (28.4%) patients with a margin < 1cm and 111 (71.6%) patients with a margin ≥1cm. At a median follow-up period of 66 months (range 3-146 months), local recurrence was observed in 36 patients (23.2%), and distant metastasis occurred in 10 patients (6.5%). In this cohort, the rates of 5-year LRFS was significantly higher in the surgical margin ≥1 cm group than in the surgical margin < 1 cm group (83.8% vs 50.4%, log-rank P< 0.001), both for the borderline (log-rank P=0.010) and the malignant PT (log-rank P< 0.001).Similarly, for both borderline (log-rank P=0.019) and malignant PT (log-rank P< 0.001), the rates of 5-year DFS was significantly higher in the surgical margin ≥1 cm group than in the surgical margin < 1 cm group (80.3% vs 47.5%, log-rank P=0.002). For 72 patients with the initial margin < 1 cm, 5-year DFS for undergoing reoperation to achieve a margin ≥1 cm and remaining with a margin < 1 cm were84.1% and 47.5%, respectively (P=0.008). In univariate analysis of the entire cohort, age, fibroadenoma surgery history, surgical methods, and surgical margins emerged as predictive factors for LRFS (P=0,003, 0.019, 0.026, and0.001, respectively), whereas age, reproductive history, fibroadenoma surgery history, tumor size and surgical margins were predictors of DFS (P= 0,011, 0.025, 0.039, 0.022, and0.002, respectively).In multivariate analysis, age< 45 years (HR=2.186, 95%CI:1.105-4.328, P=0.025)and surgical margins< 1cm (HR=2.181, 95%CI:1.021-4.659, P=0.044) were independent risk factors of LRFS. Independent risk factors for DFS included tumor size>5cm (HR=2.265, 95%CI:1.113-4.606, P=0.024) and surgical margins < 1cm (HR=2.689, 95%CI:1.438-5.027, P=0.002). Conclusion. For borderline and malignant PT, surgical margins of at least 1 cm should be achieved for a better prognosis. Patients aged < 45 years with a high risk of local recurrence and larger tumor patients with poor prognosis, multiple therapy modalities may be required for these high-risk patients. Survival curves for impact of variables on LRFS and DFS Table 1 Univariate and multivariate analysis of LRFS of PTs of the breast (n=155) Table 2 Univariate and multivariate analysis of DFS of PTs of the breast (n=155) Citation Format: lu Gan, Jialin Su. Surgical Margins and prognosis of borderline and malignant phyllodes tumors of breast [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-17-01.

Clinical outcomes for olfactory neuroblastoma

BackgroundOlfactory neuroblastoma (ONB) is a rare malignant tumor arising from the olfactory neuroepithelium. The standard of care for ONB is surgical resection; however, detailed treatment protocols vary by institution. Our treatment protocol consists of endoscopic skull base surgery (ESBS) for endoscopically resectable cases and induction chemotherapy followed by craniotomy combined with ESBS for locally advanced cases, with postoperative radiotherapy performed for all cases. Chemoradiotherapy (CRT) is performed in unresectable cases. In this study, we evaluate our treatment protocol and outcomes for ONB.MethodsA retrospective review of patients with ONB was conducted. Outcomes included survival outcomes and perioperative data.ResultsFifteen patients (53.6%) underwent ESBS, 12 (42.9%) underwent craniotomy combined with ESBS, and 1 (3.6%) received CRT. The 5- and 10-year overall survival rates for all patients were 92.9% and 82.5%, respectively, with a median follow-up period of 81 months. The 5- and 10-year disease-free survival rates were 77.3% and 70.3%, respectively, and the 5- and 10-year local control rates were 88.2% and 80.2%, respectively. Patients undergoing ESBS demonstrated a significantly shorter operating time, period from operation to ambulation, hospitalization period, and less blood loss than those undergoing craniotomy combined with ESBS.ConclusionOur treatment protocol was found to afford favorable outcomes. Patients who underwent endoscopic resection showed lower complication rates and better perioperative data than those who underwent craniotomy combined with ESBS. With appropriate case selection, ESBS is considered a useful approach for ONB.

Abstract PO3-04-09: Prognoses of Patients with Hormone Receptor-Positive andHuman Epidermal Growth Factor Receptor 2-Negative BreastCancer Receiving Neoadjuvant Chemotherapy before Surgery:A Retrospective Analysis

Abstract Abstract: Purpose: To evaluate the clinical characteristics, pathological response, and prognostic significance of hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2−) breast cancer (BC) after neoadjuvant chemotherapy (NAC). Methods: A survival analysis was performed to detect the factors related to recurrence and death in 3070 consecutive patients with HR+/HER2− BC who received NAC from 2011 to 2022. All patients received current “standard of care” following neoadjuvant therapy based on guidelines, including surgery and adjuvant endocrine therapy. HER2-low was defined as immunohistochemistry (IHC) 1+ or IHC 2+ and fluorescence in-situ hybridization-negative. Results: The complete pathological response (pCR) (ypT0/is ypN0) rate was 14.5%. The clinical tumor size (cT), ER scores, PR status, and Ki67 levels were related to pCR. The 5-year disease-free survival (DFS) and overall survival (OS) rates were 82.6% and 90.4%, respectively. PR, Ki67 levels, and postmastectomy radiotherapy were independent factors for DFS and OS, and the extranodal extension (ENE) correlated with DFS. However, pCR and HER2 status were related to OS. The pCR rate in PR negativity BC was significantly higher than that in PR positivity BC (21.1% vs. 12.2%, p = 0.000), but PR negativity BC had a poorer prognosis than PR positivity BC. HER2-low BC showed high ER scores (over 50%), PR positivity, large ypT, ENE, and lymphovascular invasion but a lower pCR rate than HER2-zero BC. Patients with HER2-low BC had shorter OS than those with HER2-zero BC (p = 0.037). However, there was no difference in DFS. Conclusions: Depending on PR status and HER2 status, patients with ER positivity and HER2 negativity exhibit different pathologic complete response rates to neoadjuvant chemotherapy and long-term outcomes, especially patients with PR negativity or HER2-low status. Keywords: breast cancer; neoadjuvant chemotherapy; survival; prognosis; PR; HER2-low Citation Format: Jin Zhang, Yan Liu, Shichao Zhang. Prognoses of Patients with Hormone Receptor-Positive andHuman Epidermal Growth Factor Receptor 2-Negative BreastCancer Receiving Neoadjuvant Chemotherapy before Surgery:A Retrospective Analysis [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-04-09.

Abstract PO1-02-09: Efficacy of breast conserving treatment of minimal residual tumors after neoadjuvant therapy for breast cancer

Abstract Background. Determining the most effective drug therapy regimens is one of the top priorities in the individualization of the treatment of patients with breast cancer (BC). Achievement of pathological complete response (pCR) is important prognostic factor, and used as the surrogate primary end point in many clinical trials. According to the literature, the achievement of pCR after neoadjuvant systemic treatment (NST) in breast cancer varies from 30 to 70%. Patients who do not achieve pCR require post-neoadjuvant treatment, even when reaching minimal size of residual tumors. Initially, primary minimal tumors are characterized by high survival rates, which are proved by international and domestic studies. It is required to clarify the survival rates in the presence of a minimal residual tumor (ypT < 10mm) after neoadjuvant systemic therapy and to compare with primary minimal forms of breast cancer (pT1a-b N0M0), characterized by the most favorable prognosis. Objective. Improvement of the effectiveness of treatment of residual minimal forms (ypT1a-b) of BC after NST. Determination of the correlation between the schemes of NST and the rates of tumor response based on the results of postoperative pathological reports including RCB scale. Methods. The study included 602 patients aged 18–65 years with early and locally advanced I–IIIC stage T1-3N1-3M0 breast cancer,who underwent complex or combined treatment. This study included patients treated at the N.N. Petrov National Medical Research Center of Oncology from 2015 to 2021 Conclusion. After reaching a complete pathomorphological response of the tumor to NST (RCB 0), the 5-year disease-free (DFS) and overall (OS) survival rates (DFS – 78.5%; OS 90.4%) were inferior to the survival rates of patients with primary minimal breast cancer (pT1ab N0M0) [DFS – 86.4%; OS – 98.6%]. Neoadjuvant chemotherapy regimens that allow achieving a pathological complete response in triple-negative and HER2- positive breast cancer have been defined. An assessment of adverse factors that affect the effectiveness of breast conserving treatment and correlate with a deterioration in overall survival was performed. Results. Our data analysis revealed that the survival rates (DFS and OS) of patients with minimal residual tumor after neojuvant systemic therapy were not comparable with those in the group of patients with primary minimal breast cancer. Data analysis revealed the most effective combinations of drugs expressed in the rates of pathomorphological response according to the RCB scale. An assessment of adverse factors that affect the effectiveness of organ-preserving treatment and correlate with a deterioration in overall survival was performed. Citation Format: Roman Pesotsky, Vladimir Semiglazov, Petr Krivorotko, Tengiz Tabagua, Konstantin Zernov, Alexander Emelyanov, Viktoria Mortada, Nikolay Amirov, Daria Ulrikh, Valerii Levchenko, Yana Bondarchuk, Diana Enaldieva, Nestan Bekkeldieva, Konsantin Zirov, Sergey Yerechshenko, Vladislav Evseev, Kirill Rychagov, Sergey Novikov, Maria Kazantseva, Larisa Gigolaeva, Elena Zhiltsova, Denis Nesterov, Olga Ivanova, Tatiana Semiglazova. Efficacy of breast conserving treatment of minimal residual tumors after neoadjuvant therapy for breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-02-09.

Abstract PO3-17-05: Clinical Characteristics and Outcomes of Patients Receiving Adjuvant Paclitaxel and Trastuzumab (APT regimen) for HER2-Positive Early-Stage Breast Cancer in Brazil: A Real-World Evidence

Abstract Introduction: The APT trial established adjuvant paclitaxel and trastuzumab (TH) as the standard of care for HER2-positive early-stage breast cancer with tumor size ≤ 3 cm and no more than one lymph-node micrometastasis. This single-arm phase II trial demonstrated favorable long-term outcomes, with a 3-year invasive disease-free survival (IDFS) rate of 98.7% (95% CI 97.6 – 99.8%). In an updated follow-up analysis, the 10-year IDFS and overall survival (OS) rates were 91.3% (95% CI 88.3 – 94.4%) and 94.3% (95% CI 91.8 – 98.3%), respectively. Nevertheless, outcomes observed in real-world scenarios have frequently been less favorable than those observed in clinical trials. We aimed to characterize the population receiving the APT regimen in clinical practice and evaluate if real-world outcomes align with those observed in the pivotal clinical trial. Methods: This retrospective cohort study included patients with HER2-positive early-stage breast cancer treated between 2015 and 2023 at four Brazilian cancer institutions, including public and private hospitals. Clinical and demographic data, treatment details, and outcomes were collected from electronic records. The primary endpoints were the 3-year and 7-year invasive disease-free survival (IDFS) rates. Secondary endpoints included overall survival (OS) and factors associated with IDFS. Survival analysis employed the Kaplan-Meier method, and Cox regression assessed prognostic factors. Results: A total of 133 patients treated with the APT regimen were evaluated, with a median age of 56 years (range 20–83). The majority had no special type breast carcinoma (92.4%), grade 2 (63.4%) or grade 3 (34.3%) tumors, no angiolymphatic invasion (76.3%), positive estrogen receptor (69.9%), positive progesterone receptor (55.6%), and node-negative disease (94.7%). Tumor staging distribution was as follows: T1a (12%), T1b (23.3%), T1c (49.6%), and T2 (13.5%). Most patients (95.4%) received the APT regimen as per guideline recommendations, while 3.8% received it due to contraindication to other therapies. With a median follow-up of 45.8 months, 8 patients (5.8%) experienced an invasive disease event or death from any cause: 5 (3.8%) had distant recurrence, 1 (0.8%) had local recurrence, and 2 (1.5%) died without recurrence. Notably, these events occurred in patients receiving the APT regimen according to standard indications, except for one patient with N+ disease and a contraindication to another regimen. The recurrence rate according to the T stage is presented in the Table. The 3-year IDFS rate was 100% (95% CI not applicable). All events occurred after the 3-year time point, resulting in a 7-year DFS rate of 80.8% (95% CI 62.7–90.7%). No prognostic factors related to IDFS were identified. Four patients died during the study period, yielding a 7-year OS rate of 88.0% (95% CI 61.6–96.6%). Conclusion: While the baseline characteristics of this cohort resembled those of the APT trial, the long-term outcomes observed in the real-world setting were less favorable. Further investigation is required to determine the reasons for this discrepancy, underscoring the necessity for larger real-world data studies to validate these findings. Recurrence rate according to T stage XX XX Citation Format: Giselle Carvalho, Renata Colombo Bonadio, Pedro Bergmann, Marina Nishimuni, André Rossi, Cristiano Souza, Gabriel Guimarães, Laura Testa, José Bines. Clinical Characteristics and Outcomes of Patients Receiving Adjuvant Paclitaxel and Trastuzumab (APT regimen) for HER2-Positive Early-Stage Breast Cancer in Brazil: A Real-World Evidence [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-17-05.

Abstract PO3-20-01: ASTEFANIA: a Phase III study of ado-trastuzumab emtansine plus atezolizumab or placebo as adjuvant therapy in patients with residual invasive breast cancer after neoadjuvant HER2-targeted therapy and chemotherapy

Abstract BACKGROUND Ado-trastuzumab emtansine (T-DM1) is the standard of care for adjuvant treatment of patients (pts) with HER2-positive early breast cancer (eBC) who have invasive residual disease after preoperative treatment with taxane and HER2-targeted therapy. However, a high unmet need remains in some higher risk subgroups (e.g., inoperable or lymph node-positive, hormone receptor-negative disease) who have 3-year invasive disease-free survival (IDFS) rates of 76%. Exploratory analyses suggest that addition of the programmed death-ligand 1 (PD-L1) inhibitor atezolizumab to T-DM1 results in longer progression-free survival compared with T-DM1 alone in pts with previously treated PD-L1-positive metastatic BC. PD-L1/programmed death-1 inhibitors may have a different effect in eBC, as they result in improved pathologic complete response in early triple-negative BC regardless of PD-L1 status. ASTEFANIA evaluates atezolizumab plus T-DM1 in PD-L1-unselected pts with higher risk residual invasive breast cancer after neoadjuvant treatment. TRIAL DESIGN ASTEFANIA is a Phase III, randomized, double-blind, multicenter, study in pts with centrally confirmed HER2-positive eBC with residual invasive disease at surgery after neoadjuvant chemotherapy and HER2-directed treatment including ≥9 weeks of taxane and ≥9 weeks of trastuzumab. Within 12 weeks of primary surgery, pts are randomized 1:1 to intravenous (IV) T-DM1 3.6 mg/kg every 3 weeks (q3w) plus atezolizumab 1200 mg IV q3w or T-DM1 3.6 mg/kg IV q3w plus placebo IV q3w for 14 cycles. Radiotherapy and/or endocrine therapy is administered per local standards. Randomization is stratified by clinical stage at presentation, hormone receptor status, preoperative HER2-directed therapy, and PD-L1 status. ELIGIBILITY CRITERIA Eligible pts have clinical stage cT4/any N/M0, any cT/N2–3/M0, or cT1–3/N0–1/M0 at presentation. Those with cT1–3/N0–1 disease must have pathologic evidence of residual invasive carcinoma in axillary lymph node(s) at surgery. Pts with cT1mi/T1a/T1b/N0 disease are not eligible. AIMS The primary endpoint is IDFS. Secondary endpoints include overall survival, safety, and patient-reported outcomes. STATISTICAL METHODS The log-rank test will be used to compare IDFS between the treatment arms, according to the protocol-defined stratification factors. The Cox proportional hazards model, stratified by the protocol-defined stratification factors, will be used to estimate the hazard ratio between the two treatment arms and its 95% confidence intervals. ACCRUAL As of Jun 28, 2023, 789 pts of the target of 1,700 have been enrolled. CONTACT INFORMATION For more information or to refer a patient, email global.rochegenentechtrials@roche.com or call 1-888-662-6728 (USA only). Clinicaltrials.gov number NCT04873362. Originally presented at the ESMO Congress 2021, 202TiP, Peter Schmid et al. – Reused with permission. Further information is available in Future Oncology 2022; 18:3563–3572. Submitted with permission from Future Medicine & Future Science, part of the Future Science Group. Citation Format: Peter Schmid, Thomas Bachelot, Giampaolo Bianchini, Nadia Harbeck, Sherene Loi, Yeon Park, Aleix Prat, Leslie Gilham, Thomas Boulet, Nino Gochitashvili, Estefania Monturus, Chiara Lambertini, Beatrice Nyawira, Adam Knott, Sara Hurvitz. ASTEFANIA: a Phase III study of ado-trastuzumab emtansine plus atezolizumab or placebo as adjuvant therapy in patients with residual invasive breast cancer after neoadjuvant HER2-targeted therapy and chemotherapy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-20-01.

Abstract PO3-01-02: Real world outcomes of neoadjuvant therapy with Trastuzumab and Pertuzumab associated with carboplatin and docetaxel (TCHP) in HER2+ early breast cancer patients unfit for anthracyclines: a retrospective cohort comparative study

Abstract Backgound Neoadjuvant chemotherapy (CT) with anti-HER2 blockade using trastuzumab (H) and pertuzumab (P) is a standard of care for patients (pts) with HER2-positive early-stage Breast Cancer (eBC). Historically, taxanes (T) and anthracyclines (A) have been the mainstays of (neo)adjuvant CT in this setting, but the added benefit of A in the era of anti-HER2 therapy has been questioned. This study aimed to assess the effectiveness, cardiac safety, and cost-effectiveness of an anthracycline-free regimen (TCHP) in a real-world population of pts deemed unfit for A, compared to pts treated with the standard regimen of doxorubicin and cyclophosphamide plus dual-blockade associated with docetaxel (AC-DHP) at a single Portuguese Comprehensive Cancer Center. Methods This retrospective cohort study included a consecutive series of female eBC HER2+ pts who initiated primary treatment with TCHP between July 2018 and August 2022. The primary endpoint was pathological complete response (pCR), and secondary endpoints were cardiac safety and disease-free survival (DFS). The outcomes were compared with a historical database of eBC HER2+ pts who started primary treatment with AC-DHP between August 2015 and May 2021. Clinical data was collected from medical and administrative records. Descriptive statistics were used to describe categorical and continuous variables, and the Kaplan-Meier method was used for DFS analysis. Costs analysis employed the micro-costing technique, considering individual medical direct costs from diagnosis until surgery. Multivariate logistic regression models were used for effectiveness analysis and the gamma general model for costs analysis. The incremental cost-effectiveness ratio (ICER) was calculated using the pCR rate as a measure of effectiveness. Results A total of 233 and 23 pts were included in the TCHP and AC-DHP groups respectively. Reasons for choosing the anthracycline-free regimen in the TCHP group were primarily age-related frailty (52%), medical comorbidities (26%), and previous exposure to anthracyclines (22%). The TCHP pts were older (median age 71 years, range [45-77] vs. 47 years [24-70]) and had lower baseline Left Ventricular Ejection Fractions (LVEF) (median 65% [51-80] vs. 60% [56-73]), with a higher proportion of hormone receptor (HR) negative pts (78.3% vs. 33.0%). Clinical stages were balanced between groups, but the TCHP group had a higher nodal involvement (N+) (73.9% vs. 61.8%). The pCR rates were higher in the TCHP group (65.2% vs. 46.1%, HR 0.98 [95% CI 0.36 - 2.70]). Subgroup analysis by HR status showed comparable pCR rates: 77.1% vs. 74.1% in HR- pts and 40% vs. 39.7% in HR+ pts. Cardiac safety analysis indicated a median decrease in LVEF of 9% in both the TCHP and AC-DHP groups, with 43.5% of TCHP pts experiencing a decline of 10% or more, and 13.0% dropping below 50%. In comparison, these figures were 44.2% and 3.9%, respectively, in the AC-DHP group. At the end of the follow-up, only one patient in the TCHP group with a LVEF < 50% persisted with mild symptoms of chronic heart failure. The median follow-up time for DFS events, starting from surgery, was 31.1 months in the TCHP group and 45.7 months in the AC-DHP group, with 1-year DFS rates of 91.3% and 100%, respectively. The ICER analysis indicated that TCHP was cost-effective, as the incremental cost for achieving an additional pCR in similar subgroups can be outweighed by later cost savings, mainly due to further adjuvant treatment with trastuzumab instead of TDM-1. Conclusions In a real-world population of HER2+ eBC patients unfit for anthracyclines, the TCHP regimen demonstrated a higher overall pCR rate compared to a historical control treated with the AC-DHP regimen, along with an acceptable cardiac safety profile. These results support the broader use of the TCHP regimen in HER2+ eBC pts, as recommended by current NCCN guidelines. However, larger studies involving similar populations are needed to provide higher levels of evidence. Citation Format: Ricardo Pinto, Rita Calisto, Patrícia Redondo, Ana Silva, Pedro Castro, Rute Fernandes, Raquel Teixeira, Diana Mata, Ana Ferreira, Maria Bento, Cláudia Vieira. Real world outcomes of neoadjuvant therapy with Trastuzumab and Pertuzumab associated with carboplatin and docetaxel (TCHP) in HER2+ early breast cancer patients unfit for anthracyclines: a retrospective cohort comparative study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-01-02.

Sublobectomy and lymph node sampling are adequate for patients with invasive lung adenocarcinoma presenting as pure ground glass nodules.

In this study, we aimed to investigate the prognosis of invasive lung adenocarcinoma that manifests as pure ground glass nodules (pGGNs) and confirm the effectiveness of sublobectomy and lymph node sampling in patients with pGGN-featured invasive adenocarcinoma (IAC). We retrospectively enrolled 139 patients with pGGN-featured IAC, who underwent complete resection in two medical institutions between January 2011 and May 2022. Stratification analysis was conducted to ensure balanced baseline characteristics among the patients. The 5-year overall survival (OS) and disease-free survival (DFS) rates were compared between the groups using Kaplan-Meier survival curves and log-rank test. The 5-year OS and DFS rates for patients with IAC presenting as pGGNs after surgery were 96.5% and 100%, respectively. No lymph node metastasis or recurrence was observed in any of the enrolled patients. There was no statistically significant difference in the 5-year OS between patients who underwent lobectomy or sublobectomy, along with lymph node resection or sampling. IAC presented as pGGNs exhibited low-grade malignancy and had a relatively good prognosis. Therefore, these patients may be treated with sublobectomy and lymph node sampling.

Laparoscopic Spleen-Preserving Hilar Lymphadenectomy for Advanced Proximal Gastric Cancer Without Greater Curvature Invasion

Splenic hilar lymphadenectomy has been recommended for locally advanced proximal gastric cancer (APGC) involving the greater curvature. However, it is unclear whether laparoscopic spleen-preserving splenic hilar lymphadenectomy (LSPSHL) is associated with a long-term survival benefit for APGC without greater curvature invasion. To present the 5-year follow-up data from a randomized clinical trial that compared laparoscopic total gastrectomy (D2 group) with D2 plus LSPSHL (D2 + No. 10 group) among patients with resectable APGC. This is a post hoc secondary analysis of a randomized clinical trial that enrolled 536 patients with potentially resectable APGC (cT2-4a, N0 or N+, and M0) without greater curvature invasion from January 5, 2015, to October 10, 2018. All patients were tracked for at least 5 years. The final follow-up was on October 30, 2023. Patients were randomly assigned in a 1:1 ratio to the D2 + No. 10 or D2 groups. The 5-year disease-free survival (DFS) and overall survival (OS) rates were measured. Recurrence patterns and causes of death were compared. A total of 526 patients (392 men [74.5%]; mean [SD] age, 60.6 [9.6] years) were included in the modified intent-to-treat analysis, with 263 patients in each group. The 5-year DFS rate was 63.9% (95% CI, 58.1%-69.7%) for the D2 + No. 10 group and 55.1% (95% CI, 49.1%-61.1%) for the D2 group (log-rank P = .04). A statistically significant difference was observed in the 5-year OS between the D2 + No. 10 group and the D2 group (66.2% [95% CI, 60.4%-71.9%] vs 57.4% [95% CI, 51.4%-63.4%]; log-rank P = .03). The No. 10 lymph node exhibited a therapeutic value index (TVI) of 6.5, surpassing that of Nos. 8a (TVI, 3.0), 11 (TVI, 5.8), and 12a (TVI, 0.8). A total of 86 patients in the D2 + No. 10 group (cumulative incidence, 32.7%) and 111 patients in the D2 group (cumulative incidence, 42.2%) experienced recurrence (hazard ratio, 0.72; 95% CI, 0.54-0.95; P = .02). The multivariable competing risk regression model demonstrated that D2 + No. 10 remained an independent protective factor for a lower 5-year cumulative recurrence rate after surgery (hazard ratio, 0.75; 95% CI, 0.56-1.00; P = .05). There was a significant difference in the 5-year cumulative recurrence rate at the No. 10 lymph node area between the 2 groups (D2 + No. 10 group vs D2 group: 0% vs 2.3% [n = 6]; P = .01). This post hoc secondary analysis of a randomized clinical trial found that laparoscopic total gastrectomy with LSPSHL can improve the prognosis and reduce recurrence for APGC without greater curvature invasion. Future multicenter studies are warranted to validate these findings. ClinicalTrials.gov Identifier: NCT02333721.

V6 vein-preserving superior segmentectomy: A potentially preferable option

ObjectiveThe increasing identification of pulmonary nodules has led to a growing emphasis on segmentectomy. Nevertheless, the surgical process for segmentectomy is complex and optimizing segmentectomy is a critical clinical concern. This study aimed to evaluate the safety and short- and long-term efficacy of V6-preserving superior segmentectomy. MethodsWe performed a retrospective analysis of patients who underwent thoracoscopic superior segmentectomy at our hospital between January 2019 and June 2020. Eligible patients were categorized into an V6 vein-preserving segmentectomy (VVPS) group and a Non V6 vein-preserving segmentectomy (NVVPS) group depending on the preservation of V6. Primary outcome measures encompassed the evaluation of surgical safety (surgical margins, 3-year overall survival, and disease-free survival), whereas secondary measures included postoperative complication rates, operative time, estimated intraoperative blood loss, length of hospital stay, and associated costs. ResultsThe analysis included a final cohort of 78 patients. In the NVVPS group (n = 43), 95.3 % of patients exceeded the tumor diameter, and no positive surgical margins were observed. The 3-year overall survival (OS) and disease-free survival (DFS) rates for the NVVPS group were 95.3 %, with no significant differences in OS (p = 0.572) and DFS (P = 0.800) compared with the VVPS group. Additionally, the median total hospitalization cost for the NVVPS group was 41,400 RMB (IQR, 38,800–43,400), which was significantly lower than that of the VVPS group, showing statistical significance (P < 0.05). No statistically significant differences were observed in the incidence of postoperative complications and length of stay between the two groups (P > 0.05). ConclusionV6-preserving superior segmentectomy is a secure and optimized surgical alternative. Its streamlined procedure facilitates easier adoption in primary healthcare facilities, rendering it a superior choice for superior segmentectomy.

Comparison of outcomes between early-stage cervical cancer patients without high-risk factors undergoing adjuvant concurrent chemoradiotherapy and radiotherapy alone after radical surgery.

For patients with early-stagecervical cancer without high-risk factors, there is no consensus regarding the optimal postoperative treatment regimen and whether postoperative concurrent radiochemotherapy (CCRT) is superior to radiotherapy (RT) alone. The medical records of patients with stage I-IIA cervical cancer, who underwent radical surgery and postoperative RT or CCRT between June 2012 and December 2017, were retrospectively reviewed. Patients with any high-risk factors, including positive pelvic lymph node(s), positive resection margin(s), and parametrial invasion, were excluded. Patients with large tumors (≥ 4 cm), deep stromal invasion (≥ 1/2), and lymphovascular space involvement were categorized as the intermediate-risk group. Patients without intermediate-risk factors were categorized as the low-risk group. A total of 403 patients were enrolled and divided into 2 groups according to postoperative treatment: RT alone (n = 105); and CCRT (n = 298). For risk stratification, patients were also divided into 2 groups: intermediate-risk (n = 350); and low-risk (n = 53). The median follow-up was 51.7 months. Patients in the intermediate-risk group and those with multiple intermediate-risk factors were more likely to undergo CCRT. For patients who underwent RT alone or CCRT in the intermediate-risk group, 5-year overall survival (OS) rates were 93.4% and 93.8% (p = 0.741), and 5-year disease-free survival (DFS) rates were 90.6% and 91.4%, respectively (p = 0.733). Similarly, for patients who underwent RT alone or CCRT in the low-risk group, the 5-year OS rates were 100.0% and 93.5% (p = 0.241), and 5-year DFS rateswere 94.4% and 93.5%, respectively (p = 0.736). Adjuvant CCRT or RT were not independent risk factors for either OS or DFS. Patients who underwent CCRT appeared to develop a higher proportion of grade ≥ 3 acute hematological toxicities than those in the RT group (44.0% versus 11.4%, respectively; p < 0.001). There was no significant difference in grade ≥ 3 chronic toxicities of the urogenital and gastrointestinal systems between the CCRT and RT groups. There was no significant difference in 5-year OS and DFS rates between patients with early-stage cervical cancer without high-risk factors undergoing postoperative CCRT versus RT alone. Patients who underwent CCRT appeared to develop a higher proportion of grade ≥ 3 acute hematological toxicities than those who underwent RT alone.

A novel classification of posterior pelvic exenteration to assess prognosis in female patients with locally advanced primary rectal cancer: a retrospective cohort study from China PelvEx collaborative

PurposeSurgical techniques and the prognosis of posterior pelvic exenteration for locally advanced primary rectal cancer in female patients pose challenges that need to be addressed. Therefore, we investigated the short-term and survival outcomes of posterior pelvic exenteration in female patients using a novel Peking classification.MethodsWe retrospectively analysed a prospective database from China PelvEx Collaborative across three tertiary referral centres. A total of 172 patients who underwent combined resection for locally advanced primary rectal cancer were classified based on four subtypes (PPE-I [64/172], PPE-II [68/172], PPE-III [21/172], and PPE-IV [19/172]) according to the Peking classification; perioperative characteristics and short-term and oncological outcomes were analysed.ResultsDifferences were significant among the four groups regarding colorectal reconstruction (p < 0.001), perineal reconstruction (p < 0.001), in-hospital complications (p < 0.05), and urinary retention (p < 0.05). The R0 resection rates for PPE-I, PPE-II, PPE-III, and PPE-IV were 90.6%, 89.7%, 90.5%, and 89.5%, respectively. The 5-year overall survival rates of the PPE-I, PPE-II, PPE-III, and PPE-IV groups were 73.4%, 68.8%, 54.7%, and 37.3%, respectively. Correspondingly, their 5-year disease-free survival rates were 76.0%, 62.5%, 57.7%, and 43.1%, respectively. Notably, the PPE-IV group demonstrated the lowest 5-year overall survival rate (p < 0.001) and 5-year disease-free survival rate (p < 0.001).ConclusionThe Peking classification can aid in determining suitable surgical techniques and conducting prognostic assessments in female patients with locally advanced primary rectal cancer.

Postoperative Hypofractionated Intensity-Modulated Radiotherapy With Concurrent Chemotherapy in Cervical Cancer

Prospective data assessing the safety of hypofractionated (40 Gy in 16 fractions) radiotherapy (RT) among patients who receive postoperative concurrent chemoradiotherapy for cervical cancer are lacking. To evaluate the acute toxic effects of hypofractionated pelvic intensity-modulated radiotherapy (IMRT) with concurrent chemotherapy among women with cervical cancer who underwent radical hysterectomy. The POHIM-CCRT (Postoperative Hypofractionated Intensity-Modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer) study was designed as a multicenter, phase 2 nonrandomized controlled trial that accrued and followed up patients from June 1, 2017, to February 28, 2023. In total, 84 patients were enrolled from 5 institutions affiliated with the Korean Radiation Oncology Group. Eligible patients experienced lymph node metastasis, parametrial invasion, or positive resection margins after radical hysterectomy for treatment of confirmed cervical cancer. Postoperative pelvic radiation using hypofractionated IMRT with 40 Gy in 16 fractions to the whole pelvis combined with concurrent chemotherapy. The primary end point was incidence of acute grade 3 or higher gastrointestinal tract, genitourinary, and hematologic toxic effects (based on the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0) in the evaluable population during RT or within 3 months after RT completion. Of 84 patients enrolled, 5 dropped out prior to RT, and data from 79 patients were analyzed. The patients' median (IQR) age was 48 (42-58) years, and the median (IQR) tumor size was 3.7 (2.7-4.5) cm. Of these patients, 31 (39.7%) had lymph node metastasis, 4 (5.1%) had positive resection margins, and 43 (54.4%) had parametrial invasion. Grade 3 or higher acute toxic effects occurred in 2 patients (2.5% [90% CI, 0%-4.8%]). After a median (IQR) follow-up of 43.0 (21.1-59.0) months, the 3-year disease-free survival rate was 79.3%, and the overall survival rate was 98.0%. Findings from this nonrandomized control trial indicated that postoperative pelvic irradiation combined with concurrent chemotherapy using hypofractionated IMRT with 40 Gy in 16 fractions was safe and well-tolerated in women with cervical cancer. Studies assessing long-term toxic effects and oncological outcomes with longer follow-up periods are needed. ClinicalTrials.gov Identifier: NCT03239613.

Association of the Specimen and Tumor Bed Margin Status with Local Recurrence and Survival in Open Partial Laryngectomy.

Background/Objectives: Positive margins are associated with locoregional recurrence in early laryngeal cancer. The aim of this study was to evaluate the impacts of specimen-driven (ex vivo) positive margins on patients with early-stage laryngeal cancer whose tumor bed (defect-driven) margins had been negative. Methods: A retrospective study was performed on 60 consecutive T1b/T2 glottic cancer patients who underwent open frontolateral laryngectomy. The intraoperative margins were obtained from the tumor bed. Their recurrence and disease-free survival were evaluated. In all cases, negative margins were obtained from the surgical bed. The impact of positive margins from the specimen was evaluated in a paraffin study. Results: Among 10 patients with positive margins in the specimen, six experienced local relapse, and among 50 patients with negative margins in the specimen, three developed recurrence. The 5-year disease-free survival rates were 37.5% and 93.9%, respectively (p < 0.001; log-rank). Even with negative margins in the surgical bed, patients with positive margins in the specimen at the final histopathological examination had a 3.5-fold higher chance of developing local recurrence than those with negative margins (HR = 13.993; 95% CI: 3.479-56.281; p < 0.001; univariate Cox regression). Conclusions: Specimen-driven positive margins represent a significant risk factor for local recurrence, even under negative margins at the tumor bed.

[Role of neoadjuvant rectal score in prognosis and adjuvant chemotherapy decision-making in locally advanced rectal cancer following neoadjuvant short-course radiotherapy and consolidation chemotherapy].

Objectives: To assess the prognostic impact of the neoadjuvant rectal (NAR) score following neoadjuvant short-course radiotherapy and consolidation chemotherapy in locally advanced rectal cancer (LARC), as well as its value in guiding decisions for adjuvant chemotherapy. Methods: Between August 2015 and August 2018, patients were eligible from the STELLAR phase III trial (NCT02533271) who received short-course radiotherapy plus consolidation chemotherapy and for whom the NAR score could be calculated. Based on the NAR score, patients were categorized into low (＜8), intermediate (8-16), and high (＞16) groups. The Kaplan-Meier method, log rank tests, and multivariate Cox proportional hazard regression models were used to evaluate the impact of the NAR score on disease-free survival (DFS). Results: Out of the 232 patients, 24.1%, 48.7%, and 27.2% had low (56 cases), intermediate (113 cases), and high NAR scores (63 cases), respectively. The median follow-up period was 37 months, with 3-year DFS rates of 87.3%, 68.3%, and 53.4% (P＜0.001) for the low, intermediate, and high NAR score groups. Multivariate analysis demonstrated that the NAR score (intermediate NAR score: HR, 3.10, 95% CI, 1.30-7.37, P=0.011; high NAR scores: HR=5.44, 95% CI, 2.26-13.09, P＜0.001), resection status (HR, 3.00, 95% CI, 1.64-5.52, P＜0.001), and adjuvant chemotherapy (HR, 3.25, 95% CI, 2.01-5.27, P＜0.001) were independent prognostic factors for DFS. In patients with R0 resection, the 3-year DFS rates were 97.8% and 78.0% for those with low and intermediate NAR scores who received adjuvant chemotherapy, significantly higher than the 43.2% and 50.6% for those who did not (P＜0.001, P=0.002). There was no significant difference in the 3-year DFS rate (54.2% vs 53.3%, P=0.214) among high NAR score patients, regardless of adjuvant chemotherapy. Conclusions: The NAR score is a robust prognostic indicator in LARC following neoadjuvant short-course radiotherapy and consolidation chemotherapy, with potential implications for subsequent decisions regarding adjuvant chemotherapy. These findings warrant further validation in studies with larger sample sizes.

Effectiveness and Safety of Radiofrequency Ablation versus Liver Resection in the Treatment of Early-stage Hepatocellular Carcinoma: A Systematic Review and Meta-analysis.

To systematically evaluate the efficacy and safety of radiofrequency ablation and liver resection in the therapeutic management of early-stage hepatocellular carcinoma. We conducted a comprehensive search of domestic and foreign databases including PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), and Wanfang to retrieve literature on radiofrequency ablation and liver resection for the treatment of early hepatocellular carcinoma. The retrieved literature underwent thorough screening, and relevant data were extracted. Following the evaluation of the literature's quality, Meta-analysis was performed using RevMan 5.4 software. In this study, a total of 11 documents were selected, comprising 1334 patients with hepatocellular carcinoma. Meta-analysis results indicated that there was no statistically significant difference in the 1-year overall survival rate [Relative risk (RR) = 1.01, 95% confidence intervals (CI) (0.98; 1.04)] and the 3-year overall survival rate [RR = 0.95, 95% CI (0.90; 1.01)] between the radiofrequency ablation and liver resection groups (p > 0.05). Similarly, there was no statistically significant difference in the 1-year disease-free survival rate [RR = 0.94, 95% CI (0.87; 1.01)] between the two groups. However, the 3-year disease-free survival rate [RR = 0.84, 95% CI (0.74; 0.96)] of patients in the radiofrequency ablation group was significantly lower than that in the hepatectomy group (p < 0.05). Notably, the incidence of complications [RR = 0.42, 95% CI (0.33; 0.55)] was significantly lower in the radiofrequency ablation group compared to the hepatectomy group. Conversely, the local recurrence rate [RR = 1.45, 95% CI (1.22; 1.73)] was significantly higher in the radiofrequency ablation group compared to the hepatectomy group (p < 0.05). During the treatment of hepatocellular carcinoma, hepatectomy demonstrates superior clinical efficacy compared to radiofrequency ablation, particularly in its ability to control tumor recurrence. However, radiofrequency ablation presents with fewer complications and a higher level of safety. These findings can serve as a valuable foundation for clinicians when selecting the most suitable treatment approaches for liver cancer.

Comparison of the safety and efficacy of robotic natural orifice specimen extraction surgery and conventional robotic colorectal cancer resection: a propensity score matching study.

Robotic resection is widely used to treat colorectal cancer. Although the novel natural orifice specimen extraction surgery (NOSES) results in less trauma, its safety and effectiveness are relatively unknown. In the present study, we used propensity score matching to compare the effectiveness and safety of NOSES and robotic resection for treating colorectal cancer. Present retrospective cohort study included patients who underwent robotic colon and rectal cancer surgery between January 2016 and December 2019 at the Department of Gastrointestinal Surgery, the Second Xiangya Hospital of Central South University. The intraoperative time, intraoperative bleeding, postoperative recovery, postoperative complications, and survival status of the conventional robotic colorectal cancer resection (CRR) (78 patients) and NOSES (89 patients) groups were compared. These results showed that no significant differences were observed between the two groups in terms of early postoperative complications, operation time, and the number of lymph nodes dissected. Compared with the CRR group, NOSES group had shorter postoperative exhaust time [3.06 (0.76) vs. 3.53 (0.92)], earlier eating time [4.12 (1.08) vs. 4.86 (1.73)], lesser intraoperative bleeding [51.23 (26.74) vs. 67.82 (43.44)], lesser degree of pain [80.8% vs. 55.1%], and shorter length of hospital stay [8.73 (2.02) vs. 9.50 (3.45)]. All these parameters were statistically significant (P < 0.05). However, no significant differences were observed in the 3-year overall survival rate and disease-free survival rate between both groups (P > 0.05). Collectively, robotic NOSES is a safe and effective approach for treating rectal and sigmoid colon cancers, could decrease intraoperative bleeding and postoperative complications, and accelerate the speed of intestinal function recovery.

Changes of biochemical factors and the effect on recurrence of medullary thyroid carcinoma after surgery

ObjectiveMedullary thyroid carcinoma (MTC) is a rare malignancy secreting calcitonin (Ctn). We aimed to analyze the relationship between Ctn levels at different time points in patients with MTC, and evaluate its predictive effect on recurrence. MethodsA retrospective study of patients diagnosed with MTC in a large medical center were conducted in northern China. The interrelationships between preoperative Ctn, normalization of postoperative serum Ctn at the first month (NPS), and long-term biochemical cure as well as their predicting roles on structural recurrence were assessed. ResultsA total of 212 patients were included in this study. The median follow-up time was 59.5 months. The 5- and 10-year cumulative disease-free survival rates were 81.5 % and 66.8 %, respectively. NPS (OR: 216.33, 95 % CI: 28.69–1631.09, P < 0.001) and absence of structural recurrence (OR: 61.71, 95 % CI: 3.90–975.31; P = 0.003) were associated with biochemical cure. Non-biochemical cure (OR: 28.76; 95 % CI: 2.84–290.86; P = 0.004, HR: 14.63, 95 % CI: 2.27–94.07, P = 0.005), larger tumor size (OR: 8.79, 95 % CI: 2.12–36.40, P = 0.003, HR: 5.41, 95 % CI: 2.04–14.37, P = 0.001), and multifocality (OR: 4.02, 95 % CI: 1.06–15.17, P = 0.040, HR: 3.00, 95 % CI: 1.18–7.60, P = 0.021) were unfavorable independent predictors of structural recurrence and disease-free survival. For sporadic MTC confined to the thyroid lobe, there was no difference in biochemical or structural prognosis between the different surgeries in the subgroup analysis. ConclusionsNPS, rather than preoperative Ctn, predicted long-term biochemical cure for MTC. Non-biochemical cure, larger tumor burden including larger tumor size and multifocality at initial surgery, served as worse prognostic predictors.

Survival and safety analysis of COVID-19 vaccine in Chinese patients with non-small cell lung cancer.

Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. We aimed to assess the safety and efficacy of the COVID-19 vaccines in Non-Small Cell Lung Cancer (NSCLC) patients. Patient self-reported adverse events related to vaccines were recorded by follow-up through a uniform questionnaire. Survival analysis was performed by Kaplan-Meier method. A multivariate analysis was performed by the Cox proportional hazard regression model to determine the effect of each variable on the survival of lung cancer patients. A total of 860 patients with NSCLC on treatment were enrolled. Mean age was 57 years in patients with early stage group and 62 years in advanced stage group. The vaccination rate was 71.11% for early-stage patients and 19.48% for advanced-stage patients; most of them (86.5%) received the COVID-19 inactivated virus (Vero cell) vaccine (Coronavac; Sinovac). The most common systemic adverse reaction was weakness. The main reason for vaccine refusal in those unvaccinated patients was concern about the safety of vaccination in the presence of a tumor and undergoing treatment (56.9% and 53.4%). The 1-year disease-free survival (DFS) rate was 100% for vaccinated and 97.4% for unvaccinated early-stage patients. Then we compared the progression-free survival (PFS) of vaccinated (median PFS 9.0 months) and unvaccinated (median PFS 7.0 months) advanced stage patients (p = 0.815). Advanced NSCLC patients continued to be divided into groups receiving radio-chemotherapy, immunotherapy, and targeted therapy, with no statistical difference in PFS between the groups (p > 0.05). The median overall survival (OS) of vaccinated patients was 20.5 months, and that of unvaccinated patients was 19.0 months (p = 0.478) in advanced NSCLC patients. COVID-19 vaccination is safe for Chinese NSCLC patients actively receiving different antitumor treatments without increasing the incidence of adverse reactions, and vaccination does not affect cancer patient survival.