Indication For Neoadjuvant Chemotherapy Research Articles

Breast cancer: agreement between residual tumor size after neoadjuvant chemotherapy measurement with different imaging methods and the histological data

BackgroundThe evaluation of residual tumor size post-neoadjuvant chemotherapy (NAC) could have an impact on surgical planning. Accurate measurement may avoid overly radical surgery or reduce the need for repeat surgery. The purpose of this study is to evaluate the size of residual tumor after NAC using mammography and ultrasound or MRI and thereby establish which imaging method shows most agreement with histological result.MethodsData from 125 patients, from 40 to 86 years old, with primary breast cancer and indication for neoadjuvant chemotherapy were analyzed in a retrospective study. All patients underwent conventional imaging (mammography and ultrasound) or MRI in addition to conventional imaging, after NAC and before surgery. Intra-class correlation (ICC) was calculated, and a Bland–Altman plot was used to determine the agreement between imaging residual tumor size (from US/mammography and MRI) and histological residual tumor size. The results were divided into the groups: invasive ductal carcinoma (IDC) + ductal carcinoma in situ (DCIS), invasive ductal carcinoma (IDC), invasive lobular carcinoma (ILC) and “other tumors” (i.e., mucinous carcinoma).ResultsOf 125 analyzed patients, 44 (34.65%) underwent MRI and 81 (65.35%) had conventional imaging only. Agreement between residual tumor size founded on MRI and histological size is stronger than the data from conventional imaging.ConclusionsMRI performance was generally superior to conventional imaging, and it may be considered the most appropriate test to evaluate the residual tumor size post-NAC before surgery.

Prognostic Evaluation of HER2-positive Early Breast Cancers Using Clinico-pathological Criteria.

HER2-positive breast carcinomas (BCs) generally behave more aggressively and show higher cytological and histological grade than HER2-negative BCs. However, the clinical properties of HER2-positive early BCs have not been studied extensively. Hence, the therapeutic significance of neoadjuvant chemotherapy (NAC) for this BC remains debatable. We retrospectively examined the clinicopathological features of 94 HER2-positive early BCs who perioperatively received anti-HER2 drugs, without undergoing NAC prior to surgery. The patients' five year-disease free survival (DFS) and overall survival (OS) rates were 95.6% and 100%, respectively. Univariate analysis demonstrated significant differences in distant metastasis-free survival (DMFS) between clinical and pathological tumor stages (T stages). Pathological T1 stage and clinical T1 stage tumors showed significantly higher DMSF than pT2-3 and cT2-3 (p=0.0002 and 0.0294). Multivariate analysis disclosed no significant differences in DFS, OS, and DMFS with respect to preoperative clinical tumor stage, patient age, type of surgery, postoperative therapy, and pathological factors. Recurrences occurred in nine patients: four (4.3%) and five (5.3%) patients showed local and distant recurrences, respectively. One patient with cT2 BC died of disease. Interestingly, four of the five BCs with distant recurrence pathologically demonstrated lymph vessel invasion. The prognoses of patients with HER2-positive stage cT1/2N0M0 BC were highly favorable. The indications for NAC in small, localized, and node-negative HER2-positive BC should be carefully assessed based on the presence of a larger tumor size, postoperative pathological evaluation of tumor size, and lymph vessel invasion.

68Ga-Labeled Fibroblast Activation Protein Inhibitor PET/CT for the Early and Late Prediction of Pathologic Response to Neoadjuvant Chemotherapy in Breast Cancer Patients: A Prospective Study.

68Ga-labeled fibroblast activation protein inhibitor (68Ga-FAPI) PET/CT has demonstrated promising clinical results, with a higher SUVmax and tumor-to-background ratio (TBR) in breast cancer (BC) patients than 18F-FDG PET/CT. Here, we aimed to evaluate the suitability of 68Ga-FAPI PET/CT for the early and late prediction of the pathologic response to neoadjuvant chemotherapy (NAC) in BC. Methods: Twenty-two consecutive patients with newly diagnosed BC and an indication for NAC were prospectively included. All patients underwent standard chemotherapy and 68Ga-FAPI PET/CT at baseline, after 2 cycles of NAC (PET2), and 1 wk before surgery (PET3). SUVmax was measured in the primary tumor region and positive regional lymph nodes. The expression of fibroblast activation protein in the primary lesion was analyzed by immunohistochemistry. Results: Seven patients (31.8%) achieved a pathologic complete response (pCR), and 15 (68.2%) had residual tumors. Thirteen patients (59.1%) showed concentric withdrawal of the primary tumor, and 9 (40.9%) showed diffuse withdrawal. Between PET2 and PET3, the ΔSUVmax of the primary tumor (R 2 = 0.822; P = 0.001) and metastatic lymph nodes (R 2 = 0.645; P = 0.002) were significantly correlated. The absolute values of SUVmax and TBR at PET2 and PET3 were lower in patients with pCR than in those without pCR (P < 0.05). Moreover, a larger ΔSUVmax at any time point was strongly associated with pCR (P < 0.05). Similar downward trends in SUVmax, TBR, and ΔSUVmax were observed in the pattern of primary tumor reduction. For predicting pCR, the optimal cutoff values for ΔSUVmax after 2 chemotherapy cycles, ΔSUVmax before surgery, TBR after 2 chemotherapy cycles, and TBR before surgery of the primary tumor were 3.4 (area under the curve [AUC], 0.890), 1.1 (AUC, 0.978), -63.8% (AUC, 0.879), -90.8% (AUC, 0.978), 7.6 (AUC, 0.848), and 1.4 (AUC, 0.971), respectively. Immunohistochemistry showed that the SUVmax and TBR of 68Ga-FAPI PET/CT were positively correlated with fibroblast activation protein expression (P < 0.001 for both). Conclusion: Assessment of early changes in 68Ga-FAPI uptake during NAC by 68Ga-FAPI PET/CT can predict pCR and primary tumor concentric withdrawal in BC patients. 68Ga-FAPI PET/CT has great potential for the early and late prediction of the pathologic response to NAC in BC.

Indications for neoadjuvant chemotherapy in older patients undergoing esophagectomy for esophageal cancer.

To investigate the indications for neoadjuvant chemotherapy (NAC) in esophageal cancer patients aged 75years or older. We analyzed data, retrospectively, from 155 patients over 75years old, who underwent esophagectomy for esophageal cancer between 2010 and 2020. Forty-one patients underwent upfront surgery (US group) and 114 were treated with NAC followed by surgery (NAC group). We compared the patient backgrounds and perioperative outcomes including prognosis, between the two groups. The NAC group patients were significantly younger and had significantly more advanced clinical stage disease than the US group patients. The incidence of postoperative complications was similar in the two groups. Patients with a good pathological response to NAC had a significantly better prognosis than those with a poor response and those in the US group. Among patients with a performance status (PS) of 0, the 5-year OS rate was 56.5% in the NAC group and 38.1% in the US group (HR = 0.63, 95% CI 0.35-1.12). Among those with a PS of 1-2, the 5-year OS rates were 28.1% and 57.1%, respectively (HR = 1.69, 95% CI 0.99-2.89; P = 0.037 for interaction). NAC did not improve the postoperative prognosis of older esophageal cancer patients with a PS of 1 or higher.

Treatment utilization and effectiveness of neoadjuvant chemotherapy comparing men and women diagnosed with breast cancer: a Swedish retrospective cohort study

PurposeEvidence supporting the use of neoadjuvant chemotherapy (NAC) in early breast cancer is based on studies mainly including women, whereas the utilization and effectiveness of NAC in men is less studied. The present study aimed to investigate the utilization and effectiveness of NAC in men and women with early breast cancer.MethodsEligible patients were identified through the Swedish National Breast Cancer Quality Register, that includes all newly diagnosed breast cancer cases in Sweden from 2008 and onwards. For the treatment utilization analysis, all patients with stage I–III between 2008 and 2020 were included (n = 82,888), whereas for the effectiveness analysis the cohort was restricted to patients receiving NAC (n = 6487). For both analyses, multivariate logistic regression models were applied to investigate potential sex disparities in NAC utilization and effectiveness, adjusted for patient- and tumor characteristics.ResultsIn the NAC utilization analysis, 487 men and 82,401 women with stage I–III were included. No statistically significant difference between sexes in terms of NAC utilization was observed (adjusted Odds Ratio (adjOR): 1.135; 95% Confidence Interval (CI) 0.606–2.128) with an overall utilization rate of 4.9% in men compared to 7.8% in women. Among the 24 men and 6463 women who received NAC, the pathologic complete response (pCR) rates were 16.7% and 21.2%, respectively (adjOR: 1.141; 95% CI 0.141–9.238).ConclusionThe present study did not find any sex disparities in NAC utilization or effectiveness in terms of pCR. This supports the current recommendations of treating men with breast cancer with the same indications for NAC as women.

The role of neoadjuvant chemotherapy in patients with primary resectable pancreatic cancer: A retrospective cohort study

Background. Currently available data on the efficacy and indications for neoadjuvant chemotherapy in patients with primary resectable pancreatic cancer are contradictory and not clearly defined.&#x0D; Aim. To conduct a comparative assessment of the effectiveness of neoadjuvant chemotherapy and primary surgical treatment followed by adjuvant chemotherapy in patients with primary resectable pancreatic cancer.&#x0D; Materials and methods. In our study, the efficacy of neoadjuvant chemotherapy was retrospectively evaluated in 45 patients and in 153 patients with primary surgical treatment and subsequent adjuvant chemotherapy.&#x0D; Results. With a median follow-up of 41.7 months. Both, recurrence free survival in the group of patients receiving neoadjuvant chemotherapy followed by surgical treatment (n=33; 73%) and in the group with surgical treatment and subsequent adjuvant chemotherapy (13.9 and 19.5 months; p=0.35) and overall survival (28.4 months vs 33.7 months; p=0.29) were no different. The CA level of 19.9500 IU/ml in the neoadjuvant chemotherapy group was observed in 20 (44.4%) patients. At the same time, surgical treatment was performed only in 11 (55%) patients. At the same time, at the CA 19.9 level 500 IU/ml, at the end of neoadjuvant chemotherapy, surgical treatment was not performed in only 3 (12%) patients (p=0.005).&#x0D; Conclusion. The long-term results of treatment of patients with primary resectable pancreatic cancer, whose first stage was neoadjuvant chemotherapy, practically do not differ from the group whose treatment began with surgery. Treatment of patients with an initially high (500 IU/ml) level of CA 19.9 is preferable to start with neoadjuvant chemotherapy. Patients who may have doubts about the likelihood of adjuvant chemotherapy (general condition, social adaptation, place of residence), it is also preferable to start treatment with neoadjuvant chemotherapy. It is necessary to change the algorithm of examination of patients, especially those with a level of CA 19.9500 IU/ml, to exclude a greater prevalence, for example, performing diagnostic laparoscopy to exclude metastases in the peritoneum.

Selective avoidance of sentinel lymph node biopsy after neoadjuvant chemotherapy in patients with HER-2 positive/triple negative breast cancer: Prospective, multi-center, single-arm study (ASLAN).

TPS624 Background: According to advanced neoadjuvant chemotherapy (NACT), which dual HER2 blockage in HER2+ BC and adding carboplatin or immunotherapy in triple-negative breast cancer (TNBC) increased pathologic complete response (ypCR) rates up to 68% and 80%. Because ypCR patients showed better survival, the indications for NACT have expanded to early BC and the expected ypCR rate has increased. Therefore, it may be reasonable to consider omitting surgery in cases with excellent responses to NACT. Several recent retrospective studies and pilot prospective studies have reported axillary pathologic complete response (ApCR) is highly correlated with breast pathologic complete response (BpCR) in HER2+ or TNBC after NACT. The current report describes the design of omission of sentinel lymph node biopsy (SLNB) after NACT in HER2+ or TNBC patients with excellent response. Similarly, EUBREAST-01 (NCT04101851) study is ongoing omission of sentinel lymph node biopsy (SLNB) after NACT in HER2+/TNBC with radiologic complete remission and a BpCR. Methods: The ASLAN trial is a prospective, multicenter, single-arm, clinical study. Five tertiary care hospitals in South Korea are participating. Inclusion criteria: women aged 20-69; cT1-3N0-1M0; HER2+ or TNBC (defined by ER-negative (&lt; 10% positive cells in IHC) and PgR-negative (&lt; 10% positive cells in IHC)); expected complete remission at physical examination and radiological expected Tumor size ≤ 2cm or non-mass enhancement ≤ 4cm at breast MRI after standard NACT; planned breast conserving surgery (BCS) with whole-breast irradiation; ECOG performance status 0-1. Exclusion criteria: SLNB before NACT; previous axillary surgery; bilateral BC. Patients who are eligible proceed BCS. After BCS, patients who showed BpCR are enrolled with omission of SLNB. Patients with no BpCR proceed with routine axillary surgery. The assumption for acceptable 5-year RFS ≥84% is based on previous study findings. The calculated total case number for per- protocol analysis is N=178. Primary endpoint: 5-year recurrence free survival. Secondary endpoint: local recurrence free survival, breast cancer specific survival, overall survival, ipsilateral axillary recurrence interval, distant metastasis free survival, contralateral breast free survival, re-operation rate according to breast biopsy after NACT, adverse event, and quality of life. The first patient was enrolled on September 2021. Among 147 patients who screened, 106 patients have been enrolled in January 2022. We plan to complete the target accrual by December 2025. Clinical trial information: NCT04993625 .

A retrospective analysis of patients administered neoadjuvant chemotherapy (NACT) with paclitaxel plus carboplatin with oral metronomic chemotherapy (OMCT) in locally advanced borderline resectable/technically unresectable head and neck cancers.

6030 Background: Neoadjuvant chemotherapy with TPF though the standard is seldom used in India due to its adverse events rate. Two drug regimen of Paclitaxel and Carboplatin (PC) though favoured has inferior outcomes. Hence, we did an analysis to estimate the efficacy and adverse event rate of addition of 3 drug metronomic schedule to PC. Methods: Patients of locally advanced head and neck cancer referred from multidisciplinary board for neoadjuvant chemotherapy and unsuitable for TPF were selected for this analysis. These patients had received 2 drug regimen of intravenous PC with 3 drug regimen of weekly methotrexate 9 mg per m2, Celecoxib 200 mg twice daily, erlotinib 150 mg once daily all administered orally. All patients underwent a response assessment at 5-7 weeks post start of therapy and we're discussed in MDT for further treatment. Adverse events were recorded in accordance with CTCAE version 4.03 and response in accordance with RECIST version 1.1. PFS and OS were estimated with Kaplan Meier method. Results: 72 patients were identified with the median age being 45 (27-80) and M:F ratio (67:5). The indication for NACT were borderline resectability in all patients.. The response rate was 61.1% and grade 3 and above adverse event rate was 33.5%. A total number of 34 among 40 borderline resectable patients underwent surgery. The overall estimated PFS and OS were 18.5 (95%CI = 14.4-22.7) months and 18.05 (95%CI = 14.2-21.8) months respectively. The three most adverse events observed were grade 3 thrombocytopenia in 2 patients (2.8%), grade 3 aspartate aminotransferase (AST) derangement in 4 patients (5.6%) and grade 3 alanine aminotransferase (ALT) in 4 patients (5.6%). Conclusions: The 5 drug combination regimen is safe, tolerable and seems to have similar efficacy as a three drug TPF regimen.

Real-world outcomes of neoadjuvant chemotherapy for breast cancer: Reflections from a community cancer center.

e18690 Background: Neoadjuvant chemotherapy (NAC) has been historically reserved for patients with locally advanced breast cancers. The utilization of NAC remains highly variable in clinical practice based on tumor size and receptor status. The decision to pursue NAC is often based on discussions by a multidisciplinary team (MDT). This study aims to look at real-world data describing the contemporary use of NAC in patients with early-stage operable breast cancer in a community cancer center and evaluate the effectiveness of MDT at our institution. Methods: We conducted a retrospective descriptive study at UMass Chan-Baystate between Oct 2018 and Oct 2020. We included patients receiving NAC for early-stage operable or locally advanced breast cancer. We excluded patients receiving neoadjuvant endocrine therapy. Primary outcomes were rates of pathological complete response (pCR) after surgery. Secondary outcomes were referral timeliness back to the breast surgeon and radiation oncologist, downstaging of cancer in the breast and axilla. Results: Ninety-three patients underwent NAC, of which 84% were white. The mean age was 56.6 yrs. Of these, 86 (93%) had clinical stage II or III cancer, and 80 (86%) had positive lymph nodes. Forty-two patients (46%) were ER positive, 28 (30%) were HER2 positive and 39 (43%) were triple negative. The most common indication for NAC was to downstage axilla (42%) and for HER2 tailoring of treatment (26%). Of the 93 patients, 23 (25%) achieved pCR; 12 (52%) had triple-negative, 7 (30%) had ER-HER2+, 3 (13%) had ER+HER2+ and 1 (4%) had ER+HER2- breast cancer. Eighty-four patients (91%) had downstaging of breast tumor, and 30 (32.3%) had axillary downstaging. Seventy-eight patients (84%) received adjuvant radiation (RT). All patients (N = 93, 100%) followed up with a surgeon prior to completion of NAC, although only 48 (50%) returned to radiation oncology. The mean time from surgery to RT was 64 days, and 6% underwent RT for more than two weeks beyond the expected time. Conclusions: Overall pCR rates were low; however, a third of patients had axillary downstaging, and the majority had breast tumor downstaging. Of the patients in our cohort who achieved pCR, the majority were triple-negative, followed by HER2 positive, consistent with overall trends. All patients were re-referred to the surgeon prior to completion of NAC for surgical planning and the average time from surgery to radiation was within national standards highlighting effective MDT involvement in the care of patients at our institution.[Table: see text]

Relationship Between Breast and Axillary Pathologic Complete Response According to Clinical Nodal Stage: A Nationwide Study From Korean Breast Cancer Society.

PurposeWe evaluated the relationship between breast pathologic complete response (BpCR) and axillary pathologic complete response (ApCR) after neoadjuvant chemotherapy (NACT) according to nodal burden at presentation. As the indications for NACT have expanded, clinicians have started clinical trials for the omission of surgery from the treatment plan in patients with excellent responses to NACT. However, the appropriate indications for axillary surgery omission after excellent NACT response remain unclear.MethodsData were collected from patients in the Korean Breast Cancer Society Registry who underwent NACT followed by surgery between 2010 and 2020. We analyzed pathologic axillary nodal positivity after NACT according to BpCR stratified by tumor subtype in patients with cT1-3/N0-2 disease at diagnosis.ResultsA total of 6,597 patients were identified. Regarding cT stage, 528 (9.5%), 3,778 (67.8%), and 1,268 (22.7%) patients had cT1, cT2, and cT3 disease, respectively. Regarding cN stage, 1,539 (27.7%), 2,976 (53.6%), and 1,036 (18.7%) patients had cN0, cN1, and cN2 disease, respectively. BpCR occurred in 21.6% (n = 1,427) of patients, while ApCR and pathologic complete response (ypCR) occurred in 59.7% (n = 3,929) and ypCR 19.4% (n = 1,285) of patients, respectively. The distribution of biologic subtypes included 2,329 (39.3%) patients with hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative disease, 1,122 (18.9%) with HR-positive/HER2-positive disease, 405 (6.8%) with HR-negative/HER2-positive disease, and 2,072 (35.0%) with triple-negative breast cancer . Among the patients with BpCR, 89.6% (1,122/1,252) had ApCR. Of those with cN0 disease, most (99.0%, 301/304) showed ApCR. Among patients with cN1-2 disease, 86.6% (821/948) had ApCR.ConclusionBpCR was highly correlated with ApCR after NACT. In patients with cN0 and BpCR, the risk of missing axillary nodal metastasis was low after NACT. Further research on axillary surgery omission in patients with cN0 disease is needed.

Covered self-expandable metallic stent versus plastic stent for preoperative endoscopic biliary drainage in patients with pancreatic cancer: a multi-center retrospective cohort study

Background Expanding indications for neoadjuvant chemotherapy (NAC) for resectable pancreatic cancer prolong the period from diagnosis to surgery. In resectable pancreatic cancer with malignant biliary obstruction (MBO), the biliary drainage method without any biliary events is ideally required to safely perform NAC as planned. Plastic stents (PS) have been traditionally used for preoperative biliary drainage; however, recently, covered self-expandable metallic stents (CSEMS) have emerged as a tool for preoperative biliary drainage. Aims To compare CSEMS with PS for preoperative biliary drainage in the management of resectable pancreatic cancer with MBO. Methods In this multicenter retrospective cohort study, we compared CSEMS with PS for preoperative biliary drainage in patients with pancreatic cancer at three tertiary care centers between 2008 and 2019. Results Of the 120 enrolled patients, 45 underwent CSEMS and 75 underwent PS. No significant difference was observed in the basic characteristics between the groups. The rate of recurrent biliary obstruction (RBO) was significantly lower and the time to RBO was significantly longer in the CSEMS group. In multivariate analysis, CSEMS was an independent factor for a longer RBO. However, pancreatitis and cholecystitis were more common in the CSEMS group. The surgery-related adverse events were not significantly different between the two groups, except for longer surgery time and time to discharge in the CSEMS group. Conclusions CSEMS for preoperative endoscopic biliary drainage in patients with pancreatic cancer reduced RBO, although the risk for pancreatitis or cholecystitis could be increased.

Traitement médical de première ligne du cancer épithélial de l’ovaire de haut grade: First-line medical treatment of high-grade epithelial ovarian cancer

In early stages, standard treatment is adjuvant chemotherapy, consisting of platinum-based combination for 6 cycles, especially in serous and endometrioid high grade carcinomas. In advanced stages, indication of neoadjuvant chemotherapy must be discussed on a case-by-case basis in multidisciplinary meetings (MDM). Bevacizumab can also be considered in the neoadjuvant setting in some circumstances, always after discussion in MDM. Carboplatin plus paclitaxel every 21 days, with or without bevacizumab remains the standard of care for first-line chemotherapy. Inhibitors of poly-(ADP-riboses) polymerases (PARPi) have been approved and are reimbursed as maintenance monotherapy in tumors carrying BRCA1 or BRCA2 mutation after complete or partial response to chemotherapy. Two recent studies demonstrated the efficacy of PARPi on progression free survival, one for niraparib single-agent in patients with high-grade ovarian carcinoma regardless of BRCA status, the other one for the combination of bevacizumab and olaparib in patients with high grade carcinoma, with positive test for homologous recombination DNA repair deficiency (regardless of BRCA status). These two new modalities of maintenance therapy are now available in compassionate use programs or post compassionate use programs. Depending on pending decisions upon reimbursement, these indications might be somewhat modified.

O-180 Oocyte vitrification for fertility preservation does not delay the initiation of neoadjuvant chemotherapy for breast cancer

Abstract Study question Does oocyte vitrification for fertility preservation (FP) delay the initiation of neoadjuvant chemotherapy for breast cancer? Summary answer The indication of neoadjuvant chemotherapy for breast cancer should not be considered as an impediment to urgent oocyte vitrification for FP. What is known already FP is considered as one of the most important issues to address for young breast cancer patients. Cryopreservation of oocytes or embryos may be considered after controlled ovarian hyperstimulation (COH) or in vitro maturation (IVM). Pregnancies have been reported after reutilization of oocytes frozen following both procedures. Although oocyte competence is better after COH, this strategy requires on average 13 days to be achieved. In addition, the safety of ovarian stimulation before tumor removal is currently not formally established. In case of neoadjuvant chemotherapy, the risk-benefit balance of COH is not well known. Study design, size, duration Retrospective cohort study including all breast cancer patients eligible for oocyte vitrification following COH or IVM before initiation of neoadjuvant chemotherapy between January 2016 and December 2020. Participants/materials, setting, methods Inclusion criteria were: female patients with confirmed non metastatic breast cancer, 18 to 40 years of age, with indication of neoadjuvant chemotherapy, who have had oocyte retrieval for FP after COH or IVM +/- cryopreservation of ovarian tissue. Various time-points related to cancer diagnosis, FP or chemotherapy were obtained from medical record review. Main results and the role of chance A total of 198 patients with confirmed breast cancer who had oocyte retrieval following COH (n = 57) or IVM +/- cryopreservation of ovarian tissue (n = 141) for FP prior to neoadjuvant chemotherapy were included. Although women in IVM group were significantly younger as compared to patients who underwent COH (31.7 ± 4.2 vs. 33.3 ± 4.0 years, p = 0.019), ovarian reserve parameters, BMI and cancer stage did not differ between the two groups. Overall, the average time from cancer diagnosis to chemotherapy start was similar between patients having undergone COH or IVM before oocyte vitrification (37.3 ± 13.8 vs. 36.9 ±13.5 days in COH and IVM groups respectively, p=0.857). Limitations, reasons for caution The time from referral to FP consultation may have influenced the type of FP. In addition, the retrospective nature of the present analysis may constitute a limitation. Moreover, the efficiency and security of the different FP strategies used has not been analysed. Wider implications of the findings Oocyte vitrification following COH or IVM was not associated with delayed breast cancer treatment in the neoadjuvant setting, so long as there was a prompt FP referral. Young patients undergoing neoadjuvant chemotherapy should be informed of these findings to avoid unnecessary anxiety due to concern for delays. Trial registration number Not applicable

Neoadjuvant chemotherapy in hormone receptor-positive/HER2-negative early breast cancer: When, why and what?

Indication for neoadjuvant chemotherapy (NACT) in HR+/HER2-negative tumors is controversial. Pathological complete response (pCR) rates range from 0 to 18 % while breast-conserving surgery (BCS) is achievable in up to 60 % of tumors. No pathological feature definitely predicts pCR; lobular and molecular luminal A tumors are less likely to achieve pCR although experiencing better outcomes. Luminal B subtype, high proliferation, lack of progesterone receptor, high tumor-infiltrating lymphocytes are positively associated with increased pCR rates but worse outcomes and the prognostic role of pCR is inconsistent across studies. Molecular intrinsic subtyping and genomic signatures appear as more accurate predictors of benefit from NACT, but larger studies are needed. Anthracycline and taxane-based chemotherapy remains the standard NACT; however, CDK 4/6 inhibitors and immune checkpoint inhibitors are under evaluation. In conclusion, NACT may be proposed for luminal tumors requiring downsizing for BCS after multidisciplinary evaluation, provided that other contraindications to BCS are excluded.

Abstract PS1-43: Axillary surgery after neoadjuvant chemotherapy in patients treated for an operable breast cancer with a proven initially positive axillary node: Preliminary results of identification and removal of the initially positive axillary node

Abstract BackgroundAlmost half of the patient with initially metastatic axillary node, treated with neoadjuvantchemotherapy (NAC) for a large operable breast cancer, has no axillary lymph node involvementat the time of surgery after NAC. Sentinel lymph node detection (SLND), performed after NAC,has a high false negative rate (FNR) when compared to FNR after primary surgery. GANEA 3 isa French prospective multi institutional ongoing trial, aimed at assessing the impact of targeting,before NAC, the initially positive node and removing it after NAC. The main objective of GANEA3 trial is the accuracy of this initially positive node to predict pathological status of the otheraxillary nodes after NAC. A total of 385 patients are required.ObjectiveThe current abstract assessed preliminary results of the detection rate of the clipped node and thedifferent methods to find it during axillary surgery based on the first 41 patients.Patients and MethodThis study is part of GANEA 3 Trial validated by scientific national board (clinicialtrials.gov:NCT03630913).Inclusion criteria: TNM stage T1-T3 N1 infiltrating breast carcinoma, indication of NAC, andsigned consent form,Exclusion criteria: more than 5 suspicious axillary nodes, inflammatory cancer, local relapse,mental disorder, pregnancy or no contraceptive method, contra-indication to NAC, NACinterrupted due to progressive disease.Design: Patients treated for an early breast cancer with NAC, axillary sonography with fine needlecytology before NAC to select patients with a proven lymph node involvement. Initially positive node identification warranted, for example with a clip. After NAC patients underwent the removalof the clipped node, a SLN detection with the combined method (patent blue and technetium) andan axillary lymph node dissection (ALND). In order to find the clipped node, during surgery thesurgeon attempted to find it with palpation and sonography. Each surgical specimen was then x-rayed before pathological examination.Studied parameters were clipped node and SLND detection rate, and the methods used to find theclipped node.ResultsFrom January 2019, to November 2019, 41 patients were enrolled, from 13 institutions, withinitially positive axillary node clipped, NAC courses and surgery after NAC.Median age was 53 (31-75), pathological subtype infiltrative ductal carcinoma (n=40) andinfiltrative lobular carcinoma (n=1), a median of 7 courses of NAC (1-16).SLN detection rate was 90% (37/41). A median number of 2 sentinel nodes were removed (1-7).The clipped node was removed in 100% of cases. The clipped node was identified by thesurgeon palpation (n=11), an axillary wire (n=13), per operative axillary sonography (n=4),surgical specimen radiography (n=11), the pathologist (n=2).The clipped node was part of SLN in 29 cases (70%). It was part of axillary lymphadenectomyspecimen in 6 cases (14.5%) and was find alone as an isolated node in 6 cases (14.5%).ConclusionThe clipped node was always found after NAC. It was mostly always part of SLN or ALNDspecimens. Further studies are needed in order to help the surgeon to remove only the clippednode. Citation Format: Celine Renaudeau, Roman Rouzier, Pierre Gimbergues, Marian Gutowski, Eva Jouve, Philippe Rauch, Charles Coutant, Christelle Faure, Catherine Uzan, Pierre-François Dupré, Vivien Ceccato, Charlotte N'go, Augustin Reynard, Isabelle Doutriaux, Loic Campion, Jean-Marc Classe. Axillary surgery after neoadjuvant chemotherapy in patients treated for an operable breast cancer with a proven initially positive axillary node: Preliminary results of identification and removal of the initially positive axillary node [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS1-43.

Indication of Neoadjuvant Chemotherapy for Patients with Colorectal Cancer Liver Metastases in our Hospital

Background: Whether neoadjuvant chemotherapy (NAC) is approriate for the patients with initially resectable colorectal cancer liver metastases (CRLM) remains controversial. The indication of NAC was examined at the surgical meeting in our hospital. The aim of this study is to retrospectively validate our indication of NAC. Patients and Methods: From 2009 to 2019, 84 patients underwent hepatectomy for CRLM. They were divided into two groups: synchronous CRLM (SM-group n=56) and metachronous CRLM (MM-group n=28) and the indication of NAC was validated. Additionally, long-term outcomes were compared between patients who received NAC (NAC(+)-patients) and those didn´t receive NAC (NAC(-)-patients). Results: NAC was performed in 41 patients (73.3%) in SM-group and 12 patients (42.9%) in MM-group. In SM-group (28 single metastasis (sgl-Met) and 28 multiple metastases (multi-Met) ), the patients with multi-Met significantly received NAC (57.1% in sgl-Met vs. 89.3% in multi-Met, p=0.01). In MM-group (15 sgl-Met and 13 multi-Met), the period from excision of the primary cancer to the development of liver metastasis was tended to be shorter in NAC(+)-patients than NAC(-)-patients (NAC (+) 309 days vs. NAC (-) 656 days, median, p=0.09). In SM-group, there was no significant difference of 5-year OS between NAC(+)-patients and NAC(-)-patients(NAC (+) 63.6% vs. NAC (-) 74.6%, p=0.93). In MM-group, there was no significant difference between NAC(+)-patients and NAC(-)-patients(90.9% vs. 82.1%, p=0.40). Conclusion: NAC for CRLM tended to be performed to the patients with multiple- synchronous-metastasis and metachronous-metastases developing within 1year after excision of the primary cancer. According to our strategy, long-term outcomes were favorable.

The survival benefit of neoadjuvant chemotherapy for resectable colorectal liver metastases with high tumor burden score.

The indications for neoadjuvant chemotherapy (NAC) in resectable colorectal liver metastases (CRLMs) remain unclear. Tumor burden score (TBS) is a prognostic tool based on tumor size and number of tumors. However, its utility in the NAC setting for initially resectable CRLM has never been investigated. TBS is a distance from the origin on a Cartesian plane to the coordinates (x, y) = (tumor size in centimeter, number of tumors). TBS < 3 was defined as "TBS-low", whereas TBS ≥ 3 as "TBS-high". Between 2008 and 2018, 102 patients who underwent hepatectomy for resectable CRLM were retrospectively analyzed using the Kaplan-Meier method and Cox proportional hazards regression models. Among the TBS-low (n = 46) and TBS-high (n = 56) groups, baseline patient characteristics were mostly similar except for TBS-related parameters. NAC was more frequently administered in the TBS-high group (p = 0.038). The overall survival (OS) rates were similar between the two groups. Subgroup analysis showed that NAC was associated with non-significantly improved 5-year OS in the TBS-high group [76.1% with NAC and 54.9% without NAC (p = 0.093)]. In multivariate analysis, NAC was an independent prognostic factor for favorable OS only in the TBS-high group, while adjuvant chemotherapy (AC) was associated with improved OS only in the TBS-low group. In patients with resectable CRLM, the TBS-high population had a survival benefit from NAC, while the TBS-low population benefited from AC. TBS may serve as an indicator for patients who will benefit from NAC.

Pre-operative Early Hormonotherapy the New Gold Standard for Operable Luminal Breast Cancer

Even though it is not yet a universally accepted, in our view, the best clinical practice in the case of operable luminal breast cancer is to begin systemic neoadjuvant hormonotherapy (HT) immediately after histologic diagnosis for the majority of patients. This strategy does not apply to patients with an indication for neoadjuvant chemotherapy.

A preoperative risk model for early recurrence after radical resection may facilitate initial treatment decisions concerning the use of neoadjuvant therapy for patients with pancreatic ductal adenocarcinoma

BackgroundNeoadjuvant chemotherapy may benefit patients with pancreatic ductal adenocarcinoma with resectable and borderline disease. Inappropriate use of neoadjuvant therapy, however, may lead to the loss of therapeutic opportunities. Until an effective prediction model of individual drug sensitivity is established, no accurate model exists to help surgeons decide on the appropriate use of neoadjuvant chemotherapy. We hypothesized that early recurrence in patients undergoing upfront, early resection may be an indication for neoadjuvant chemotherapy. Therefore, we aimed to use preoperative clinical parameters to establish a model of early recurrence to select patients at high risk for neoadjuvant chemotherapy. MethodsPatients who underwent resection for pancreatic ductal adenocarcinoma between January 2014 and November 2017 were analyzed retrospectively. After the minimum P-value approach, the patients were divided into three groups: early recurrence, middle recurrence, and late/non-recurrence. Preoperative clinicopathologic factors that could predict early recurrence were included in a Cox proportional hazards regression model for univariate and multivariate analyses. The factors related to early recurrence were included to establish nomogram and decision tree models, which were then validated in 68 patients. ResultsWe found that 235 (72.5%) of 324 patients had recurrence with a median recurrence-free survival of 210 days. The early recurrence, middle recurrence, and late/non-recurrence groups differed in preoperative carbohydrate antigen 19-9 and carcinoembryonic antigen levels, “resectability” on cross-sectional imaging, resection requiring a vascular resection, T stage, tumor size, and adjuvant chemotherapy. The best cutoff value of early recurrence was the first 162 days postoperatively. Univariate and multivariate analyses showed that selected preoperative chief complaints, lymph node enlargement and resectability on cross-sectional imaging, preoperative carbohydrate antigen 19-9 levels >210 kU/L, and a neutrophil/lymphocyte ratio >4.2 were independent predictors for early recurrence. ConclusionWe have successfully built a prediction model of early recurrence of patients with pancreatic ductal adenocarcinoma with the optimal cutoff early-recurrence value of 162 days. Our nomogram and decision tree models may be used to select those at high risk for early recurrence to guide preoperative decision-making concerning the use of neoadjuvant therapy in those patients who have “resectable” disease and not only the more classic criteria of borderline resectability.

Incidence of venous thromboembolism among patients receiving neoadjuvant chemotherapy for advanced epithelial ovarian cancer

ObjectivesNeoadjuvant chemotherapy may be considered for women with epithelial ovarian cancer who have poor performance status or a disease burden not amenable to primary cytoreductive surgery. Overlap exists between indications...