Five-year Progression-free Survival Rates Research Articles

The Effectiveness of Denosumab in Middle Eastern Patients With Giant Cell Tumor of the Bone: A Single-Center, Retrospective Study.

Giant cell tumor of the bone (GCTB) is an aggressive benign tumor, which constitutes 5% of all primary bone tumors. Denosumab, a receptor activator of nuclear factor κB ligand monoclonal antibody, inhibits osteoclast-induced bone destruction and has demonstrated promising results in patients with GCTB. However, the long-term efficacy of the drug has not been extensively studied, especially in the Middle East. In this study, we retrospectively analyzed the five-year progression-free survival (PFS) in patients with GCTB at a single Saudi center. PFS was defined as the time from diagnosis until disease progression, relapse, or death. Events were censored after five years from diagnosis. Sixty-two patients with GCTB were included in the study. The median age at diagnosis was 31.16 years, and 38 (61.3%) patients were female. Twenty-nine patients (46.8%) received denosumab during the study period. The median duration of denosumab treatment was 5.06 months, and the median number of cycles was 6. The median PFS was not reached, and the five-year PFS rate was 60.3%. Age, gender, body mass index, performance status at presentation, and tumor location had no impact on five-year PFS. Denosumab treatment prolonged PFS; however, this was not statistically significant compared to non-denosumab patients (P= 0.603). Denosumab does not seem to provide superior long-term outcomes compared to surgery alone. Although our findings are generally consistent with other studies in the literature, larger long-term studies are needed to confirm our findings.

Radiotherapy for Advanced Hodgkin Lymphoma with Initial Bulk: A Combined Analysis of Two Randomized Trials

PurposeThe role of consolidative radiotherapy (RT) in patients with advanced Hodgkin lymphoma (HL) with initial bulk is unclear. GITIL/FIL HD0607 and FIL HD0801, two randomized controlled trials with similar design and methodologies, did not identify a benefit to consolidative RT after a metabolic complete response (CR) to 6 cycles of ABVD. However, their limited sample sizes reduced statistical power to detect a small but clinically meaningful benefit to RT. Materials and MethodsIn a secondary analysis of these two phase 3 trials, reconstructed patient data were used to compare outcomes for early and complete responders randomized to no RT or RT to the site(s) of initial bulk. Estimates of progression-free survival (PFS) in the intent-to-treat (ITT) and per-protocol (PP) analyses were generated using the combined data and compared between groups using the log-rank test. ResultsA total of 412 patients were included in the ITT analysis and 373 patients were included in the PP analysis. Median age was 30-32, 42% of patients were stage IIB, and 73% of bulky sites were located in the mediastinum. For the no RT versus RT groups, 5-year ITT PFS estimates were 90.1% versus 90.1% (p=0.81). Five-year PP PFS rates were 90.9% versus 92.9% (p=0.31), respectively. There was no observed difference between no RT and RT groups in subgroups according to size of bulky disease: 5-7 cm (p=0.78), 7-10 cm (p=0.25), and >10 cm (p=0.69). ConclusionIn this combined analysis of two randomized phase 3 clinical trials, consolidative RT to initial sites of bulky nodal involvement was not associated with a PFS benefit in patients with advanced HL in metabolic CR after 2 and 6 cycles of ABVD.

Impact of prognostic nutritional index change on prognosis after colorectal cancer surgery under propofol or sevoflurane anesthesia

BackgroundThe alteration of the prognostic nutritional index (PNI) or the utilization of distinct anesthesia strategies has been linked to the prognosis of various cancer types, but the existing evidence is limited and inconclusive, particularly for colorectal cancer (CRC). Our objective was to evaluate the association between PNI change and progression free survival (PFS) and overall survival (OS) in patients treated with CRC surgery after propofol-based or sevoflurane-based anesthesia.MethodsWe conducted a retrospective analysis of 414 patients with CRC who underwent surgical resection. Among them, 165 patients received propofol-based total intravenous anesthesia (TIVA-P), while 249 patients received sevoflurane-based inhalation anesthesia (IA-S). The PNI change (ΔPNI) was calculated by subtracting the pre-surgery PNI from the post-surgery PNI, and patients were categorized into high (≥ -2.25) and low (< -2.25) ΔPNI groups. Univariate and multivariate analyses were employed to evaluate the effects of the two anesthesia methods, ΔPNI, and their potential interaction on PFS and OS.ResultsThe median duration of follow-up was 35.9 months (interquartile range: 18–60 months). The five-year OS rates were 63.0% in the TIVA-P group and 59.8% in the IA-S group (hazard ratio [HR]: 0.96; 95% confidence interval [CI]: 0.70–1.35; p = 0.864), while the five-year PFS rates were 55.8% and 51.0% (HR: 0.92; 95% CI: 0.68–1.26; p = 0.614), respectively. In comparison to patients in the low ΔPNI group, those in the high ΔPNI group exhibited a favorable association with both OS (HR: 0.57; 95% CI: 0.40–0.76; p < 0.001) and PFS (HR: 0.58; 95% CI: 0.43–0.79; p < 0.001). Stratified analysis based on ΔPNI revealed significant protective effects in the propofol-treated participants within the high ΔPNI group, whereas such effects were not observed in the low ΔPNI group, for both OS (p for interaction = 0.004) and PFS (p for interaction = 0.024).ConclusionsOur data revealed that among patients who underwent CRC surgery, those treated with TIVA-P exhibited superior survival outcomes compared to those who received IA-S, particularly among individuals with a high degree of PNI change.

Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial

ObjectiveIn the PAOLA-1/ENGOT-ov25 trial (NCT02477644), adding maintenance olaparib to bevacizumab provided a substantial progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer and homologous recombination deficiency (HRD)-positive tumors,...

Chidamide plus prednisone, cyclophosphamide, and thalidomide for relapsed or refractory peripheral T-cell lymphoma: A multicenter phase II trial.

Although the treatment of peripheral T-cell lymphoma (PTCL) has undergone advancements during the past several years, the response rate and long-term effects with respect to patients with PTCL remain unsatisfactory-particularly for relapsed or refractory (R/R) patients. This phase II trial was designed to explore the efficacy and safety of an all-oral regimen of chidamide plus prednisone, cyclophosphamide, and thalidomide (CPCT) for R/R PTCL patients who could not tolerate the standard chemotherapy for a variety of reasons. We conducted a multicenter phase II clinical trial in which we combined chidamide (30 mg twice weekly) with prednisone (20 mg daily after breakfast), cyclophosphamide (50 mg daily after lunch), and thalidomide (100 mg daily at bedtime) (the CPCT regimen) for a total of fewer than 12 cycles as an induction-combined treatment period, and then applied chidamide as single-drug maintenance. Forty-five patients were ultimately enrolled from August 2016 to April 2021 with respect to Chinese patients at nine centers. Our primary objective was to assess the overall response rate (ORR) after the treatment with CPCT. Of the 45 enrolled patients, the optimal ORR and complete response (CR)/CR unconfirmed (CRu) were 71.1% (32/45) and 28.9% (13/45), respectively, and after a median follow-up period of 56 months, the median progression-free survival (PFS) and overall survival (OS) were 8.5 months and 17.2 months, respectively. The five-year PFS and OS rates were 21.2% (95% confidence interval [CI], 7.9-34.5 %) and 43.8% (95% CI, 28.3-59.3 %), respectively. The most common adverse event was neutropenia (20/45, 44.4%), but we observed no treatment-related death. The all-oral CPCT regimen was an effective and safety regimen for R/R PTCL patients who could not tolerate standard chemotherapy for various reasons. ClinicalTrials.gov, NCT02879526.

Oncological outcomes of concurrent chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil for locally advanced squamous cell carcinoma of the external auditory canal: A single-center study.

Squamous cell carcinoma of the external auditory canal (EACSCC) is a rare condition. However, a standard treatment has not yet been established. We retrospectively evaluated the efficacy, adverse events, and feasibility of TPF-CCRT (concomitant chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil) in patients with advanced EACSCC. Thirty-five consecutive patients with advanced EACSCC (T3, T4) initially treated with TPF-CCRT at Kobe University Hospital were included. T4 diseases with invasion of the brain, internal carotid artery, or internal jugular vein were classified as T4b, and those without these features were classified as T4a. Five-year overall survival rates for T3 and T4 were 100% and 64.2%, respectively. A significant difference was observed between T4a and T4b (82.4% vs. 30%, p = 0.007). Five-year progression-free survival rates of T3, T4a, and T4b were 100%, 68%, and 20% (p = 0.022), respectively. TPF-CCRT should be considered as a plausible treatment option for advanced EACSCC.

The Therapeutic Value of Adjuvant Chemotherapy after Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

Objective: The aim of this study was to evaluate the therapeutic value and treatment-related complications of adjuvant chemotherapy after concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC). Design: The medical records of LACC patients who underwent CCRT were reviewed retrospectively. Methods: A total of 1,138 patients with LACC who had been treated at our hospital between January 2013 and December 2017 were included in the study and classified into two groups: the CCRT group, comprising 726 patients who had received only CCRT, and the CCRT + adjuvant chemotherapy (ACT) group, comprising 412 patients who had received three cycles of adjuvant chemotherapy after CCRT. 39 patients in the CCRT group and 50 patients in the CCRT + ACT group had undergone lymphadenectomy, which revealed pathology-positive lymph nodes in 22 patients and 35 patients, respectively. Progression-free survival (PFS), overall survival (OS), and adverse events were compared. Results: The median follow-up time was 61 months (range: 2–96 months). No significant differences in PFS and OS were found between the two groups (p > 0.05), but more grade 3–4 acute hematologic toxicities were observed in the CCRT + ACT group than in the CCRT group (24.8% vs. 31.8%, p = 0.01). A subgroup analysis of patients with pathology-positive lymph nodes showed that the 5-year PFS and OS rates were 76.5% and 74.9%, respectively, for the CCRT + ACT group and 45.0% and 49.2%, respectively, for the CCRT group; the differences were statistically significant (p = 0.015 and 0.042, respectively). Limitations: First, the sample size of the subgroup of patients with pathology-positive lymph nodes was too small for a confirmative conclusion. The heterogeneous population and the selection bias resulting from the retrospective design were the other flaws of our study. Conclusion: The application of adjuvant chemotherapy after CCRT may be worth investigating further for women with LACC and pathology-positive lymph nodes, but this approach is associated with an increase in acute hematology toxicities.

Chidamide Plus Prednisone, Cyclophosphamide, and Thalidomide (CPCT) for Relapsed or Refractory Peripheral T-Cell Lymphoma: A Multicenter Phase II Trial

Purpose: Peripheral T-cell lymphoma (PTCL) is a rare and heterogeneous group of aggressive lymphomas that portends an unfavorable outcome. Although the treatment of PTCL has undergone advancements during the past several years, the response rate and long-term effects with respect to patients with PTCL remain unsatisfactory-particularly for relapsed or refractory (R/R) patients. We herein conducted a prospective, single-arm phase II clinical trial to explore the efficacy and safety of an all-oral regimen of chidamide plus prednisone, cyclophosphamide, and thalidomide (CPCT) for R/R PTCL patients who could not tolerate standard chemotherapy for a variety of reasons. Methods: This was an open-label, single-arm, multicenter pivotal phase II study in which patients were enrolled at 9 centers. The flow chart of the CPCT regimen: a total of fewer than 12 cycles as an induction-combined treatment period, and then applied chidamide as single-drug maintenance. The CPCT regimen was administered orally until disease progression or unacceptable toxicity as follows: chidamide at 30 mg twice weekly, prednisone at 20 mg daily after breakfast, cyclophosphamide at 50 mg daily after lunch, and thalidomide at 100 mg daily at bedtime. Our primary objective was to assess overall response rate (ORR) after treatment with CPCT, with secondary objectives to evaluate the duration of response, one-year overall survival (OS), and one-year progression-free survival (PFS). Results: Forty-five patients were ultimately enrolled in the present study for response and safety assessments from August 2016 to April 2021 with respect to Chinese patients (the characteristics of the 45 patients with at least one treatment response assessment are listed in Figure 1A). Twenty-three patients (51.1%) were heavily pretreated before enrollment. Of the 45 enrolled patients, the optimal ORR and complete response (CR)/CR unconfirmed (CRu) were 71.1% and 28.9%, respectively, and after a median follow-up period of 56 months, the median PFS and OS were 8.5 and 17.2 months, respectively (Figure 1B). The median median duration of response (DOR) was six months with a range of 0.7-71.5 months, and most responders (41 patients, 91.1%) had a DOR more than three months. Twenty-eight patients (62.2%) exhibited a DOR over six months and 17 patients (37.8%) had a DOR over 12 months. The one-year PFS and OS rates were 42.2% (95% CI, 27.7%‒56.7%) and 57.8% (95% CI, 43.3%‒72.3%), respectively, and the five-year PFS and OS rates were 21.2% (95% CI, 7.9%‒34.5%) and 43.8% (95% CI, 28.3%‒59.3%), respectively. Although subgroup survival analysis indicated no significant differences among different histopathologies (Figure 1C and D), the median PFS (p<0.001) and OS (p<0.001) were not attained for patients who achieved CR/CRu (N=13) (Figure 1E and F). The most common grade 3/4 adverse event was neutropenia (24.5%), but we observed no treatment-related mortality. Conclusions: In conclusion, the all-oral CPCT regimen was a well-tolerated and effective treatment for R/R PTCL patients who could not tolerate standard chemotherapy for a variety of reasons. However, further studies that entail a larger sample size in different subtypes of PTCL are still required. This trial was registered in ClinicalTrials.gov (NCT02879526). Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

P008: Impact of bone marrow involvement on early PET response and progression-free survival in the HD18 trial for patients with advanced-stage Hodgkin lymphoma

Background: The prognostic role of bone marrow (BM) involvement in advanced-stage Hodgkin lymphoma is unclear, particularly for patients receiving intensive first-line treatment. We thus retrospectively examined its impact on early response and progression-free survival (PFS) among individuals receiving escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (eBEACOPP) in the HD18 trial. Patients and Methods: A total of 424 individuals were suitable for analysis, of which 124 (29%) had BM involvement according to initial positron emission tomography (PET). Patient outcome was measured by PET response after 2×eBEACOPP and five-year PFS rate. Results: After 2×eBEACOPP, 79 of the BM PET-negative individuals (26%) and 26 of the BM PET-positive patients (21%) were found to be PET-positive (odds ratio [OR] 0.74, P=0.25). The five-year PFS rate was 90.7% in BM PET-negative individuals and 91.8% for BM PET-positive patients (hazard ratio 0.82, P=0.6). In our BM PET-positive subgroup, nine (16%) of the 56 subjects with one or two sites of skeletal uptake were PET-positive after 2×eBEACOPP as compared to 17 (25%) of the 68 individuals showing three or more BM lesions (OR 1.74, P=0.23). Conclusions: The present analysis demonstrates that BM involvement, irrespective of its extent, does not lead to increased risk for a positive interim PET result or inferior PFS in advanced-stage Hodgkin lymphoma patients undergoing eBEACOPP treatment. Skeletal lesions cannot therefore be considered as an additional prognostic marker of therapy failure or disease recurrence for individuals receiving intensive first-line treatment.

Long-term follow-up of nilotinib in patients with advanced tenosynovial giant cell tumours: Long-term follow-up of nilotinib in TGCT

BackgroundDiffuse-type tenosynovial giant cell tumour (D-TGCT) is a non-malignant but locally aggressive tumour driven by overexpression of colony-stimulating factor-1 (CSF1). CSF1R inhibitors are potential therapeutic strategies for patients not amenable to surgery. We report here the long-term outcome of nilotinib in patients with advanced D-TGCT treated within a phase II prospective international study (ClinicalTrials.gov: NCT01261429). MethodsPatients were enrolled between December 2010–September 2012 at 11 cancer centres. Eligible patients had histologically confirmed D-TGCT, not amenable to surgery. Patients received nilotinib until evidence of progression, toxicity or a maximum of one year. Long-term data were retrospectively collected after the completion of the phase II trial. Patients with nilotinib treatment ≥12 weeks and follow-up ≥12 months were included for long-term analysis. ResultsForty-eight of 56 enrolled patients were included. Median treatment duration was 11 months; 31 (65%) patients completed the treatment protocol. After 102 months of follow-up (median; range 12–129), 25 patients (52%) had progression. The median progression-free survival (PFS) was 77 months. The five-year PFS rate was 53%. Fifteen patients (n = 15/46; 33%) experienced clinical worsening after 11 months (median). Twenty-seven patients (58%) received additional treatment, after which eleven patients (n = 11/27; 41%) had a second relapse. Nine patients required a subsequent treatment, primarily other CSF1R inhibitors (n = 6/9; 67%). No unfavourable long-term effects were observed. ConclusionThis long-term analysis of nilotinib for advanced D-TGCT showed that about half of the patients had progression and underwent additional treatment after 8.5 years follow-up. Contrarily, several patients had ongoing disease control after limited treatment duration, demonstrating the mixed effect of nilotinib.

RARE-18. Pediatric craniopharyngioma; single center experience in 246 cases with different management modalities

PURPOSE: To report our experience with different craniopharyngioma management strategies done for 246 patients in a single institution during a period of 14 years. METHODS: The medical records of all children with the diagnosis of craniopharyngioma treated at Children's Cancer Hospital Egypt (CCHE-57357) during the period from July 2007 to December 2021 were retrospectively reviewed. RESULTS : our registry included 246 pediatric craniopharyngiomawith median age of 7.4 years old. The main strategies of management after initial surgery were follow up, radiotherapy or administration of intracystic interferone post ommaya insertion. The number of cases in each group were 92, 147,and three respectively. Three patients were not operated upon because of heavily calcified lesions, two of them received radiotherapy while the third was kept under follow up. Overall gross or near total total excision was achieved in 31.2 % , subtotal resection was the case in 42.1% while Ommaya insertion and biopsy was done in 21.1 % of cases. Total number of patients received radiotherapy initially or on progression was 195 patients( 78.9%). The five-year overall survival was 88% (95% CI 82.9 – 93.1) while 5- year progression free survival (PFS) was 49.2% (95% CI 41.2—57.2). The five-year PFS rates for patients in the follow up group versus radiotherapy group were 25.2% and 68.7% respectively (P< 0.0001). Beta catenin was positive in 76.4% of cases that were available for testing (123/161). CONCLUSION: management of craniopharyngioma should be individualized with the main objective is the quality of life. Conservative surgery which entails gross total safe resection whenever possible or lesser extent of resection followed by radiotherapy is the main strategy followed in our institution.

Postoperative Morbidity After Radical Resection of Retroperitoneal Solitary Fibrous Tumor.

BackgroundThis study aimed to investigate the clinicopathological characteristics of retroperitoneal solitary fibrous tumor (RSFT) and the safety of radical resection.MethodsA retrospective analysis was conducted on the data of 32 RSFT patients who received surgery with curative intent from February 2011 and June 2021.ResultsThis cohort included 16 (50%) male and 16 (50%) female patients, with the median age of 52 (29 to 72) years. Tumor burden ranged from 3 to 25 (median, 10) cm. Seven patients received arterial embolization before surgery. 15 (47%) patients received radiotherapy, nine (28%) of which received preoperative radiotherapy. Most of the patients (91%) achieved complete resection with median bleeding of 400 (20 to 5,000) ml. Nine (28%) patients received packed red blood cell (RBC) transfusion, with a median of 5 (2 to 10) U. All patients had the five-year progression-free survival rate and the overall survival rate of 75.8% and 80.0%, respectively. 11 (34%) patients were found with adverse events, and four (12%) patients were found with serious postoperative complications (Clavien-Dindo ≥3), of which one (3.1%) patient died after surgery. The univariate analysis found that tumor burden (p = 0.022), packed RBC transfusion (p = 0.001) and postoperative hospital stays (0.027) were correlated with overall morbidity. The multivariate analysis found packed RBC transfusion as an independent risk factor for postoperative morbidity (HR 381.652, 95% CI, 1.597–91213.029, p = 0.033).ConclusionRSFT was confirmed as an uncommon, slow-growing and recurring tumor, with acceptable postoperative morbidity and mortality after surgical resection.

Interval Progression Serves As a Predictor of Adverse Outcomes in Patients with Multiple Myeloma

Background: Multiple myeloma (MM) remains an incurable disease, but deep, lasting remission can be achieved with induction therapy and autologous stem cell transplant (ASCT). The current ASCT treatment timeline includes a gap between the end of induction and the day of ASCT to permit correct mobilization and collection of stem cells. During this interval, some patients experience increases in their MM markers. We specifically evaluated if patients with interval progression (IP) have different outcomes post-ASCT compared to patients without IP.Methods: We completed a retrospective analysis of 482 patients who underwent ASCT at The Ohio State University Wexner Medical Center between 2011 and 2016. MM labs, including protein electrophoresis with immunofixation and free light chains, were obtained at day of diagnosis, end of induction, and day of ASCT. A 20% increase in the index protein between the end of induction and the day of ASCT was defined as IP. The primary outcomes evaluated were time-to-progression (TTP), progression-free survival (PFS), and overall survival (OS). TTP was defined as time from ASCT to disease progression, treating death without progression as a competing risk. PFS was defined as the time from ASCT until either disease progression or death, while OS was defined as the time from ASCT until death or last follow-up. Poisson regression models with robust variance were used to evaluate the associations between patients' characteristics and IP, while competing risk regression models were used for TTP analysis, and Cox regression models for OS and PFS analysis.Results: 482 patients who underwent ASCT for MM between 2011 and 2016 were studied. The patient population was primarily male (n = 296, 61.4%), Caucasian (n = 420, 87.1%), and had IgG disease (n = 269, 55.8%). MM stage at diagnosis was equally represented. Cytogenetic analysis showed 108 (22.4%) patients with 1q21 amplification, 60 (12.4%) patients with t(11;14) translocation, 33 (6.8%) patients with t(4;14) translocation, and 40 (8.3%) patients with 17p deletion. More than 80% of patients underwent maintenance therapy following ASCT.One hundred and fifty-six (32.3%) patients were defined as having IP. Patients in the IP group were significant more likely to have LC disease (p = 0.0018), but no other patient characteristics varied significantly between the two groups. LC disease (relative risk (RR adj) = 2.12, 95% CI 1.37-3.30, p = 0.001) and deletion 17p (RR adj = 1.62, 95% CI 1.08-2.42, p = 0.02) were associated with increased risk of IP on multivariate analysis (MVA).Five-year PFS rates were 47.2% and 36.8% in the non-IP and IP groups, respectively. Five-year cumulative progression rates were 49.0% in the non-IP group and 57.8% in the IP group. Five-year OS rates were 76.8% in the non-IP group and 69.6% in the IP group. On univariate analysis (UVA), IP correlated with inferior outcomes in both TTP (hazard ratio (HR) = 1.39, p = 0.01) and OS (HR = 1.39, p = 0.04). In agreement with previous literature, other factors independently correlated with inferior TTP and OS outcomes, including MM stage, cytogenetics (amp1q, t(4;14), and del(17p)), and absence of maintenance therapy post-ASCT. On MVA, IP was no longer significantly associated with a shorter TTP (HR = 1.16, p = 0.35), but approached statistical significance in conferring inferior OS (HR = 1.40, p = 0.07). Notably, once deletion 17p was removed from the MVA, the presence of IP once again conferred significantly lower OS (HR = 1.45, 95% CI 1.01-2.07, p = 0.04), suggesting that deletion 17p, which is a significant risk factor for both IP and OS, may mediate the effect of IP. Combined, all data suggest that uncontrolled disease prior to ASCT trends towards worse long-term outcomes.Conclusion: In this study, we report the first data regarding patients who experienced rapid disease progression in the interval between induction therapy and ASCT. These patients have inferior TTP, PFS, and OS, likely due to the presence of LC disease or deletion 17p. IP may provide a valuable predictor of robustness of response to ASCT and prompt the need for additional induction cycles or alternative regimens. This is especially relevant for patients with deletion 17p. Indeed, these data support a prospective study of concepts to improve outcomes for patients with IP prior to ASCT. DisclosuresBumma: Amgen: Speakers Bureau; Janssen: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Definitive Radiotherapy for Patients With Anal Squamous Cell Carcinoma: A Retrospective Cohort Study.

BackgroundAnal squamous cell carcinoma accounts for less than 2-3% of all digestive system carcinomas. The present study aimed to determine the clinical characteristics, treatment patterns, and treatment outcomes of patients at our institution.MethodologyWe reviewed the clinical data of all consecutive patients with anal squamous cell carcinoma who were treated with definitive radiotherapy in our department between July 2009 and July 2020. Radiotherapy was delivered in 1.8-2 Gy daily fractions to a whole pelvic dose ranging from 45 to 50 Gy, followed by boost radiotherapy of 10-15 Gy, resulting in a total dose of approximately 60 Gy. Concurrent chemotherapy with radiotherapy included 5-fluorouracil/mitomycin C or 5-fluorouracil/cisplatin.ResultsA total of 14 patients with a median age of 61.5 years (range: 45-85 years) were analyzed. There were nine women and five men. The clinical T stage was T1 in two patients, T2 in six patients, T3 in two patients, and T4 in four patients. The clinical N stage was N0 in four patients and N1 in 10 patients. Patients with clinical stage III disease comprised 79% of the entire study population. For the entire cohort, the five-year overall survival rate was 83.3% and the five-year progression-free survival rate was 48.5%. One patient experienced grade 3 fecal incontinence, and the others experienced no radiation-induced severe delayed adverse events.ConclusionsThe results of our study demonstrated that definitive radiotherapy with or without chemotherapy for patients with anal squamous cell carcinoma is an effective and feasible treatment.

Prognostic impact of immune inflammation biomarkers in predicting survival and radiosensitivity in patients with non-small-cell lung cancer treated with chemoradiotherapy.

The purpose of this retrospective study was to investigate the prognostic impact of neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), derived NLR (dNLR) and systemic immune-inflammation index (SII) in predicting outcomes for patients with locally advanced non-small-cell lung cancer (NSCLC). The secondary endpoint was to evaluate the radiosensitivity in terms of response rate. Newly diagnosed locally advanced NSCLC patients were enrolled. Immune inflammation biomarkers were calculated from baseline blood samples. Patients were stratified in two groups based on optimal cut-off values for each biomarker. The associations between biomarkers and overall survival (OS), progression-free survival (PFS), local regional recurrence-free survival (LRRFS), and also response to radiotherapy were analysed. A total of 392 patients were included. Five-year OS, PFS and LRRFS rates were 14.6%, 12.1%, and 13.4% respectively. Optimal cut-off values for NLR, PLR, dNLR and SII were 3.07, 166, 2.02 and 817 respectively. Low NLR (HR 1.73, 95% CI 1.34-2.24, P < 0.001), low PLR (HR 1.37, 95% CI 1.06-1.76, P = 0.013), low dNLR (HR 1.66, 95% CI 1.29-2.13, P < 0.001) and low SII (HR 1.63, 95% CI 1.18-2.04, P < 0.001) were independent prognostic factors for OS. Low NLR, PLR, dNLR and SII were also significant prognostic factors for PFS and LRRFS. Low NLR, low dNLR and low SII groups had better radiosensitivity than compared with high NLR, high dNLR and high SII groups (P = 0.001, P = 0.001 and P = 0.012). NLR, PLR, dNLR and SII were independently associated with improved OS, PFS and LRRFS. Low NLR, dNLR and SII groups had better radiosensitivity. Immune inflammation biomarkers are promising prognostic predictors which can be obtained easily and inexpensively.

Five-year results of nivolumab for the treatment of non-small cell lung cancer in clinical practice of the N.N. Blokhin Russian Cancer Research Center

Introduction. Lung cancer remains the one of the most common and fatal cancers in the world. For a long time, chemotherapy was the only treatment option for metastatic lung cancer. Currently, immunotherapy became the one of the preferred options of treatment.The purpose of our work was to evaluate the long-term results of using the PD-1 inhibitor nivolumab in real-world settings.Materials and methods. 108 pretreated patients with metastatic NSCLC were included in this non-randomized, observational study. The median follow-up time was 54.5 months.Results. Median overall survival was 8.8 months (6-12, 95% CI). The five-year overall survival rate was 19.4%. Median progressionfree survival was 3.9 months (3-5, 95% CI). The five-year progression-free survival rate was 7.7%. Overall response rate (ORR) was 18%. In patients with ORR, the median overall survival was not achieved. Prolongation of immunotherapy after disease progression had a positive effect on the overall survival of patients. Clinically significant immuno-related adverse events developed in 21% of patients, but only 7.3% showed the development of adverse events grade 3-4 that required discontinuation of immunotherapy. A rare complication that we met was a case of encephalopathy, to which the patient achieved durable complete response despite discontinuation of immonotherapy.Conclusion. Received survival, efficacy and safety data may inform treatment decisions for patients with metastatic NSCLC in real world settings.

Comparison of surgical and oncologic outcomes in patients with clear cell ovarian carcinoma associated with and without endometriosis.

To compare clinical characteristics, surgical and oncologic outcomes of clear cell ovarian cancer among patients with cancer arising from endometriosis, cancer coexisting with endometriosis, and cancer without endometriosis. A retrospective chart review of patients diagnosed with clear cell ovarian cancer during January 1998-March 2013 was performed. All histopathology specimens were reviewed by a gynecologic pathologist and classified into one of the three following endometriosis status groups: arising group, coexisting group, or without group. The primary outcome was disease-specific survival (DSS). The secondary outcomes were progression-free survival, surgical morbidities, response rate, recurrence rate, and cancer-specific death. Finally, 249 patients were included. There were 82, 96, and 71 patients in the arising, coexisting, and without groups, respectively. Regarding baseline characteristics among groups, the without group was significantly older and had more advanced diseases. There was a significant difference in progression-free survival between the arising group and the without group (p = 0.003). Five-year progression-free survival rates were 62.8% in the arising group, 50.2% in the coexisting group, and 38.3% in the without group. DSS was not significantly different among groups. Multivariate analysis revealed ovarian surface invasion (HR = 2.76) and pelvic lymphadenectomy (HR = 0.39) to be independent prognostic factors for progression-free survival, whereas no remission after primary treatment (HR = 8.03) and pelvic lymphadenectomy (HR = 0.21) were prognostic factors for DSS. Intraoperative blood loss and residual tumor were significantly higher in the without group. Endometriosis status was found not to significantly influence surgical and oncologic outcomes in patients with clear cell ovarian cancer.

Prognostic impact of depth of response in Waldenström macroglobulinemia patients treated with fixed duration chemoimmunotherapy.

8049 Background: The treatment paradigm of Waldenström macroglobulinemia (WM) continues to evolve as new therapies expand our options for this indolent and incurable disease. While more profound responses are generally associated with longer treatment-free intervals, the impact of depth of response from fixed duration therapy in WM patients' survival needs further evaluation. In this international, multicenter cohort study, we report the prognostic impact of depth of response in WM. Methods: 319 WM patients treated with frontline fixed duration therapy [Dexamethasone/Rituximab/Cyclophosphamide (DRC), Bendamustine/Rituximab (BR), or Bortezomib/Dexamethasone/Rituximab (BDR)] were included. Response at the completion of therapy (6 months) was used in a landmark analysis for progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS) (defined as time from 6 months post treatment response to event or censor). Response was defined by modified IWWM-6 criteria. Associations between clinical variables and outcomes were evaluated using Cox proportional-hazard models. Results: The median age at the time of treatment initiation was 64 years (range: 29-94), 59% were men, and risk category by International Prognostic Scoring System (IPSS)-WM was low (n=67, 23%), intermediate (n=83, 29%), and high-risk (n=141, 48%). Evaluable responses at 6 months from frontline therapy [DRC (n=105; 41%), BR (n=83; 32%), BDR (n=68; 27%)] were available in 256 patients and included in the landmark analysis. Median follow-up was 63 months (95% CI: 59-70). The rate of major response (PR or better) at 6 months was 74% for the entire cohort. Five-year PFS rates from completion of therapy for patients who attained major response vs. those who did not were 71% and 43%, respectively (p&lt;0.001). Five-year TTNT rates for patients who attained major response vs. not were 84% and 54%, respectively (p&lt;0.001). Five-year OS rates for patients who attained major response vs. not were 92% and 77%, respectively (p&lt;0.001). In multivariable analyses including other WM prognostic factors evaluated at initiation of frontline therapy, attaining a major response at 6 months was associated with superior PFS (HR 0.33, p&lt;0.001), TTNT (HR 0.23, p&lt;0.001), and OS (HR 0.31, p=0.001–Table). Conclusions: Achieving a major response at 6 months after frontline chemoimmunotherapy emerges as a significant prognostic factor for PFS, TTNT and OS in patients with WM.[Table: see text]

Different prognosis of stage IIIB cervical cancer patients with lower third of vaginal invasion and those without

ObjectivePrevious studies have evaluated the prognostic factors of patients with stage IIIB cervical cancer. However, there was only one study evaluating the relationship between LTI (lower third of vaginal invasion) and the prognosis of the patients with stage IIIB cervical cancer. Our research aimed to assess different therapeutic outcomes of the stage IIIB CCP (cervical cancer patients) with or without LTI. MethodsFrom December 2007 to December 2014, patients with FIGO (International Federation of Gynecology and Obstetrics, 2009) stage IIIB cervical cancer admitted and treated in Zhejiang Cancer Hospital were enrolled and evaluated in this retrospective research. Different clinicopathological variables and treatment outcomes were analyzed by using multivariate and univariate Cox regression models and chi-square or Fisher's exact test. ResultsThe number of enrolled patients was 622, among which 74 cases were with LTI and 548 without. The two- and five-year OS (overall survival) rates in non-LTI group were 79.9% and 58.9%, and the OS rates in LTI group were 68.9% and 38.8%, respectively (P = 0.001). The two- and five-year PFS (progression-free survival) rates in non-LTI group were 63.3% and 53.1%, and the PFS rates in LTI group were 45.9% and 37.0% respectively (P = 0.002). Multivariate Cox regression analysis indicated that histological type, total treatment time, hydronephrosis, and treatment protocol were factors significantly affecting the PFS rates in stage IIIB CCP, and OS rates were associated with histological type, hydronephrosis, treatment protocol, and LTI. ConclusionsOur study showed that stage IIIB CCP with LTI had worse prognosis than those without LTI.

Grading Soft Tissue Involvement in Nasopharyngeal Carcinoma Using Network and Survival Analyses: A Two-Center Retrospective Study.

Soft tissue involvement (STI) indicates poor prognosis in nasopharyngeal carcinoma (NPC). However, only a few studies have systematically assessed this extension using network analysis. To investigate the prognostic value of STI and to propose an improved STI grading system for NPC therapy. Retrospective study. A total of 1225 consecutive patients with pathologically confirmed NPC treated with intensive-modulated radiotherapy from January 2010 to March 2014 were enrolled from two centers. T1- and T2-weighted imaging and enhanced T1-weighted imaging with fast spin echo sequence at 1.5 or 3.0T. The levator veli palatini and tensor veli palatini involvement were graded "mild," prevertebral muscle involvement, "moderate," medial pterygoid, lateral pterygoid, and the infratemporal fossa involvement, "severe" STI. The above STI sites were evaluated separately by three radiologists using MRI images and graded using network analysis. Overall survival (OS) and progression-free survival (PFS) were assessed. Kaplan-Meier method, Cox's proportional hazards model, and concordance index (C-index) were used. Five-year OS and PFS rates between mild and moderate groups (90.5% vs. 81.7%, P < 0.05 and 82.9% vs. 72.5%, P < 0.05, respectively) and between moderate and severe groups (81.7% vs. 70.4%, P < 0.05 and 72.5% vs. 61.2%, P < 0.05, respectively) revealed significant differences. The C-index of the nomogram with STI grading was higher compared with current T-classification (OS 0.641 vs. 0.604, P < 0.05 and PFS 0.605 vs. 0.581, P < 0.05, respectively). Significant OS differences were observed between patients with severe STI who underwent induction chemotherapy (IC) and those who did not (84.5% vs. 70.7%, P < 0.05). STI grading was an independent prognostic factor for OS and PFS in NPC patients and it may be help to improve the accuracy in predicting survival outcomes. Patients with severe STI might benefit from IC to improve OS. 4 TECHNICAL EFFICACY: Stage 2.