Predictive value of the Lung Immune Prognostic Index (LIPI) in locally advanced non-small-cell lung cancer (NSCLC) patients treated with concurrent chemoradiotherapy (CCRT) in the multicenter retrospective study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21076-e21076
Author(s):  
Yuko Oya ◽  
Go Saito ◽  
Akihiro Tamiya ◽  
Hayato Kawachi ◽  
Daichi Fujimoto ◽  
...  
Keyword(s):  
Predictive Value ◽  
Advanced Nsclc ◽  
Statistical Significance ◽  
Locally Advanced ◽  
Multivariable Analysis ◽  
Prognostic Index ◽  
Progression Free Survival ◽  
Rank Test ◽  
Kaplan Meier ◽  
Locally Advanced Nsclc

e21076 Background: PD-L1 inhibitor, durvalumab has been approved since the PACIFIC study showed its efficacy as consolidation therapy after CCRT for locally advanced NSCLC. But predictive factor for the efficacy of CCRT on this post PACIFIC era have not been known. LIPI has been proposed as a new biomarker for the anti-PD-1 therapy of advanced NSCLC. In this study, we investigated the usefulness of LIPI as a predictive marker in multicenter cohort of patients with locally advanced NSCLC who received CCRT as initial treatment. Methods: 219 patients with available baseline LIPI were reviewed. The progression free survival (PFS) was estimated by the Kaplan-Meier method, and LIPI were calculated at baseline. Kaplan-Meier estimates of PFS and recurrence were compared using the log-rank test for trend. Multivariable analysis was conducted using the Cox and logistic regression models, respectively, adjusted for age, sex, ECOG-PS, smoking, histology, TNM stage, chemotherapy regimens, Body mass index (BMI), PD-L1 status, EGFR or ALK mutation, and baseline LIPI. Results: 62.5% (n = 137) of the patients had a good (0 factors) LIPI, while 37.5% (n = 82) had intermediate (1 factor) and poor (2 factors) LIPI respectively. In multivariable analysis, good LIPI (0 factors) were significantly associated with longer PFS (HR = 0.46, 95% CI 0.28-0.75; P < 0.01) as did ECOG-PS0 (P < 0.01), ≤stageIIIA (P < 0.01), being treated with durvalumab after CRT (P = 0.04). There were no difference in the patient characteristics between good LIPI and intermediate/poor LIPI, significantly. Higher LIPI (1 or 2 factors) were strongly prognostic factor for recurrence after CCRT in multivariate analysis (P = 0.04), along with ECOG-PS1≤ (P < 0.01), stage IIIB≤ (P < 0.01). Conclusions: The good LIPI predictive value for PFS and disease control in patients treated with CCRT was confirmed. Although a strong statistical significance, we needs to be confirmed further with longer follow-up and prospective study.

Updated results of a phase III trial comparing standard thoracic radiotherapy (RT) with or without concurrent daily low-dose carboplatin in elderly patients (pts) with locally advanced non-small cell lung cancer (NSCLC): JCOG0301.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7017-7017 ◽  
Author(s):  
Hiroaki Okamoto ◽  
Shinji Atagi ◽  
Masaaki Kawahara ◽  
Akira Yokoyama ◽  
Nobuyuki Yamamoto ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Cox Regression ◽  
Smoking Status ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Concurrent Chemotherapy ◽  
Phase Iii ◽  
Rank Test ◽  
Cox Regression Analysis ◽  
Locally Advanced Nsclc

7017 Background: We previously reported the superiority of combined chemo-radiotherapy (CRT) over RT alone in elderly pts with locally advanced NSCLC (Atagi et al. ECCO2011). One and a half years follow-up data from last accrual are presented. Methods: Pts older than 70 years with unresectable stage III NSCLC were randomized to either RT alone (RT arm), a total dose of 60 Gy, or CRT arm including the same RT plus concurrent chemotherapy with carboplatin 30 mg/m2/day, 5 days/week × 20 days. The primary endpoint was overall survival (OS). The planned sample size was 100 pts in each arm with one-sided alpha of 5% and 80% power to detect a difference in median survival time (MST) from 10 months in RT arm to 15 months in CRT arm. Results: Between Sep 2003 and May 2010, 200 pts were randomized. Baseline characteristics were similar in the RT (n=100) vs CRT (n=100) arms: median age, 77 vs 77 years; stage IIIB (n), 46 vs 49; PS 0/1/2 (n), 41/55/4 vs 41/56/3. The second planned interim analysis was performed 10 months after the completion of accrual. In accordance with the pre-specified stopping rule, the JCOG Data and Safety Monitoring Committee recommended early publication of this trial because of the difference in OS favoring the CRT arm. In the updated analysis, OS was better in the CRT arm than the RT arm (HR = .64, 95% CI = .46-.89, one-sided p = .0033 by stratified log-rank test). In each arm (RT/CRT), MST was 16.5 mo/22.4 mo with 3-year OS of 14.3%/34.6%, response rate of 44.9%/54.6% (p=.201) and median progression-free survival of 6.9 mo/8.9 mo (p=.003). Gr 3/4 toxicities were (RT/CRT): neutropenia 0%/57.3%, infection 4.1%/12.5%, dysphagia 0%/1.0%, late RT toxicities 7.4%/7.5%. The pattern of relapse site and post-protocol treatment were almost similar between the arms. Even after an adjustment by the Cox regression analysis with six variables [stage, PS, sex, age, histology, smoking status], CRT arm showed better survival (HR=.71, p=.038). Conclusions: The CRT using daily carboplatin is considered to be the standard treatment for elderly pts with locally advanced NSCLC.

Hypertension and myelosuppression as biomarkers of sunitinib efficacy in Chinese patients (pts) with metastatic renal cell carcinoma (mRCC).

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 426-426 ◽  
Author(s):  
Shukui Qin ◽  
Jie Jin ◽  
Jun Guo ◽  
Jin-Wan Wang ◽  
Fang-Jian Zhou ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Statistical Significance ◽  
Objective Response ◽  
Progression Free Survival ◽  
Chinese Patients ◽  
Rank Test ◽  
Open Label ◽  
Exact Test ◽  
Kaplan Meier ◽  
Open Label Phase

426 Background: In an open-label, phase IV study of sunitinib as 1st-line treatment (Tx) in Chinese pts with mRCC, median progression-free survival (PFS) and overall survival (OS) were 61.7 and 133.4 wk, respectively; objective response rate (ORR) was 31.1% (Ann Oncol 2012;23:851P). We retrospectively investigated correlations between on-Tx hypertension (HTN), neutropenia (N), and thrombocytopenia (T) and efficacy endpoints in pts from this trial. Methods: HTN was defined by either maximum systolic blood pressure ≥140 mm Hg (S-HTN) or maximum diastolic blood pressure ≥90 mm Hg (D-HTN). Using CTCAE assessment, N grade ≥2 and T grade >1 were used as cut-points for the analyses. Median PFS and OS were estimated by Kaplan−Meier method. The log-rank test was used to compare PFS and OS between groups with and without HTN, N grade ≥2, or T grade >1. Fisher’s exact test was used for ORR. Results: 102 pts were included in the HTN analyses, 60% with S-HTN versus 40% without S-HTN. Pts with S-HTN had greater ORR and longer PFS and OS than pts without S-HTN (Table). (Results were similar with D-HTN; see Table.) 103 pts were included in the N and T analyses, 67% with N grade ≥2 versus 33% with N grade <2, and 56% with T grade >1 versus 44% with T grade ≤1. Pts with N grade ≥2 had significantly greater ORR and significantly longer PFS and OS than pts with N grade <2 (Table). Pts with T grade >1 had greater ORR and significantly longer PFS and OS than pts with T grade ≤1 (Table). Conclusions: The developments of N grade ≥2 and T grade >1 during Tx with sunitinib were significantly associated with better outcome. Median PFS was more than twice as long for pts with S-HTN as for those without S-HTN, but the association did not reach statistical significance. [Table: see text]

Three fluoropyrimidine-based regimens in second-line therapy following nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer: Efficacy and tolerance in clinical practice.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 370-370
Author(s):  
Anne Laure Pointet ◽  
David Tougeron ◽  
Simon Pernot ◽  
Astrid Pozet ◽  
Dominique Bechade ◽  
...  
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Statistical Significance ◽  
Performance Status ◽  
Locally Advanced ◽  
Rank Test ◽  
Line Treatment ◽  
Second Line ◽  
Secondary Resection ◽  
Kaplan Meier ◽  
Metastatic Sites

370 Background: Combination of nab-paclitaxel plus gemcitabine (N+G) has recently become a valid first-line treatment (1L) in metastatic pancreatic adenocarcinoma (MPA) in patients (pts) with performance status (PS) of 0,1 or 2, but there is currently no standard second-line treatment (2L) after this new 1L option. We evaluated survival outcomes and tolerability of three usual fluoropyrimidine-based regimens: FOLFOX, FOLFIRI or FOLFIRI.3 (FOLFIRI1/3), and FOLFIRINOX after N+G failure in MPA pts. Methods: We prospectively identified 138 pts from 11 French centers who received 1L N+G for unresectable pancreatic adenocarcinoma. After disease progression or unacceptable toxicity, we excluded pts with locally advanced cancer, or who underwent secondary resection/chemoradiotherapy. Three subgroups of 2L chemotherapy were identified: FOLFOX, FOLFIRI1/3 and FOLFIRINOX regimens. Response was evaluated by RECIST criteria, progression-free survivals (PFS1, PFS2), and overall survival (OS1, OS2) were calculated using Kaplan-Meier method and compared with the Log-rank test. Results: 61 pts with MPA received a 2L. Persistent neuropathy was present in 27% of pts. Median age was 71.7 years [41-83]. PS was 0, 1 or 2. Median 1L duration, number of metastatic sites, PS, CA19.9, albumin, and bilirubin levels, and persistent neuropathy grade were statistically comparable between the 3 subgroups. Median OS for all 2L pts was 6.0 months [4-8]. Third line regimen was used in 32.8% of 2L pts without statistical significance between the subgroups. Main grade 3/4 adverse events reported were thrombocytopenia (18%), anemia (7.7%), neutropenia (21.4%) and nausea (5.4%). No toxic deaths occurred. Conclusions: This study suggests a clinical benefit and a manageable toxicity profile of 2L fluoropyrimidine-based regimens after N+G failure in patients with MPA, in particularly combined with irinotecan.[Table: see text]

Clinical and prognostic implications of sarcopenia in patients affected by locally advanced NSCLC.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20046-e20046
Author(s):  
Sabrina Rossi ◽  
Luca Disconzi ◽  
Luca Toschi ◽  
Giovanna Finocchiaro ◽  
Laura Giordano ◽  
...  
Keyword(s):  
Skeletal Muscle ◽  
Induction Chemotherapy ◽  
Advanced Nsclc ◽  
Locally Advanced ◽  
Stage Iii ◽  
Rank Test ◽  
Skeletal Muscle Index ◽  
Computed Tomography Images ◽  
Locally Advanced Nsclc ◽  
The Impact

e20046 Background: Sarcopenia is a loss of skeletal muscle mass that has been studied as prognostic factor in several cancers. Retrospective studies have suggested that sarcopenia is associated with poorer survival outcomes and with an increase of major chemotherapy toxicities resulting in dose reduction and delay. This study examined the value of sarcopenia in patients with stage III non-small cell lung cancer (NSCLC). Methods: This retrospective analysis includes 68 patients affected by stage III NSCLC treated with induction chemotherapy followed by surgery or radical radiation therapy in our cancer center. Weight and height were obtained from medical records at diagnosis. Skeletal muscle index (SMI) was measured by the analysis of electronically stored computed tomography images obtained before the start of chemotherapy; sarcopenia was defined by international consensus as a SMI≤39 cm2/m2 for women and ≤55 cm2/m2 for men. Kaplan-Meier method and Log-Rank test were used to determine the impact of sarcopenia on overall survival (OS) and progression-free survival (PFS). Exact Fisher test and Chi-squared test were used to establish the association between the presence of sarcopenia and other variables. Results: A total of 68 patients (stage 3A = 39; stage 3B = 29) with performance status 0-1 and median age 67 yrs were analyzed. Forty-five patients (66%) were sarcopenic: 100% of underweight patients (BMI ≤18.5), 83% of patients with normal weight (BMI 18.5-24.9), 56% of overweight patients (BMI 25-29.9) and 30% of obese (BMI≥30). Sarcopenia was not associated with age≥70 yrs (p = 0.67), Charlson Comorbidity Index (p = 1.00), stage (p = 0.53), response rate to chemotherapy (p = 0.78) or toxicities of grade≥3 (p = 0.83). Median OS in sarcopenic patients was 18.2 months compared with 33.2 months in nonsarcopenic patients (p = 0.03); the difference in terms of PFS was not statistically significant (10.7 vs 14.9 months; p = 0.19). Conclusions: Sarcopenia is associated with shorter OS in patients with locally advanced NSCLC but it seems not related with worse response to induction chemotherapy or higher toxicities. These data should be validated in larger prospective clinical studies.

Association of immune related adverse events with superior outcomes in patients with hepatocellular carcinoma (HCC) treated with nivolumab.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16630-e16630
Author(s):  
Lorena Ostios-Garcia ◽  
David Ramiro-Cortijo ◽  
Mary Linton Bounetheau Peters ◽  
Andrea J. Bullock
Keyword(s):  
Adverse Events ◽  
Cox Regression ◽  
Statistical Significance ◽  
Onset Time ◽  
Progression Free Survival ◽  
Categorical Variables ◽  
Rank Test ◽  
Cancer Outcomes ◽  
Exact Test ◽  
Kaplan Meier

e16630 Background: Nivolumab, an anti-PD1 antibody, is FDA approved in patients (pts) with HCC. Anti-PD-1 promotes hyperstimulation of host immunity and is associated with a spectrum of toxicities known as immune-related adverse events (irAEs). In other malignancies, higher rates of irAEs are associated with improved cancer outcomes. This study shows correlation between irAEs and efficacy in pts with HCC treated with nivolumab. Methods: Demographic and toxicity data were collected retrospectively on all pts with HCC treated with nivolumab at a single institution from Jan 2012 – Sept 2019. Response was evaluated using RECISTv1.1. Adverse events were assessed according to CTCAEv5.0. Categorical variables were assessed by Fisher's exact test. Survival was estimated with the Kaplan-Meier method and compared using the log-rank test. Univariate and multivariate analyses were performed by the Cox-regression model. Results: 30 pts were treated; irAEs were detected in 16 (53%). There was no difference in baseline characteristics among those who did and did not experience irAEs (Table). The most frequent irAEs were elevated AST/ALT (n = 7; 44%), rash (n = 4; 25%), and hypothyroid (n = 4; 25%). 3 G3 (rash and transaminitis) and 1 G4 AE (pured red cell apalasia) were observed. Among all pts, overall response rate (RR) and disease control rate (DCR) were 13 and 50%, respectively. Median progression free survival (PFS) and overall survival (OS) were 27 and 56 weeks (w), respectively. The RR and DCR were higher among irAEs vs non-irAEs, although this did not reach statistical significance (RR 25 vs 0%; p = 0.05; DCR 62 vs 35%; p = 0.19). Median PFS and OS were longer in those with irAEs vs non-irAE; PFS 33 vs 16 w (HR: 0.26; CI 95%: 0.076-0.89; p = 0.028); (OS 69 vs 21 w HR: 0.18; CI 95%: 0.05-0.58; p = 0.002). On multivariate analysis, viral etiology was associated with prolonged PFS (p = 0.002) and MELD was associated with reduced OS (p = 0.004). Conclusions: Development of irAEs was associated with prolonged PFS and OS in pts with HCC treated with nivolumab. Further study is needed to determine whether type of irAE, onset time, or duration affect cancer outcomes. [Table: see text]

PET-directed chemoradiation (CRT) with induction FOLFOX compared to induction carboplatin/paclitaxel (CP) in patients with locally advanced esophageal adenocarcinoma (EA).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4554-4554
Author(s):  
Rebecca Carr ◽  
Meier Hsu ◽  
Kay See Tan ◽  
Manjit S. Bains ◽  
Matthew Bott ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Multivariable Analysis ◽  
Disease Free Survival ◽  
Complete Response ◽  
Rank Test ◽  
Complication Rates ◽  
Trimodality Therapy ◽  
Kaplan Meier ◽  
Multivariable Analyses

4554 Background: Induction chemotherapy with PET-directed CRT and surgery is the standard treatment for locally advanced EA at our institution. Following results of the CALGB 80803 trial, FOLFOX has recently replaced CP as the preferred induction regimen. Methods: We retrospectively evaluated patients with locally advanced EA treated with induction CP vs FOLFOX, followed by trimodality therapy between January 2010 and June 2019. Patients treated with CP with RT followed by surgery without induction chemo were also included. We compared pathological complete response (pCR) and near pCR (ypN0 with ≥90% response) rates in the induction FOLFOX group to the induction CP and no-induction groups. Univariable and multivariable analyses were used to adjust for confounding factors. Disease-free survival (DFS) was estimated by the Kaplan-Meier method and compared between groups using max-combo weighted log rank test. Results: 445 patients were included. Patients in the induction FOLFOX group had significantly higher pCR and near pCR rates vs induction CP patients. Notably, pCR rate was 38% among FOLFOX PET responders vs 19% in non-responders. In multivariable analysis, compared to induction CP, induction FOLFOX administration was an independent predictor of near pCR (OR: 2.22, 95%CI: 1.20-4.20, p = 0.012). Compared to 24% pCR rate among no-induction patients, induction FOLFOX pCR rate was slightly higher at 32%. DFS by 2-years was higher in induction FOLFOX compared to no-induction-treated patients (62% vs. 42%, p = 0.05). Postoperative complication rates were similar among the three groups. Conclusions: PET-directed CRT with FOLFOX instead of CP improves pCR and near pCR rates. Improved DFS was observed in the FOLFOX vs no-induction patients. Longer follow-up is needed to confirm any survival benefits. [Table: see text]

Impact of chemoradiotherapy (CRT) on immune-related tumor microenvironment and the efficacy of anti-PD-1 therapy after the recurrence of CRT in unresectable locally advanced NSCLC patients.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21719-e21719
Author(s):  
Masayuki Shirasawa ◽  
Tatsuya Yoshida ◽  
Noriko Motoi ◽  
Yuji Matsumoto ◽  
Yuki Shinno ◽  
...  
Keyword(s):  
Tumor Microenvironment ◽  
Advanced Nsclc ◽  
Locally Advanced ◽  
Antibody Therapy ◽  
Progression Free Survival ◽  
Expression Levels ◽  
Locally Advanced Nsclc ◽  
The Status ◽  
History Of ◽  
Nsclc Patients

e21719 Background: Chemoradiotherapy (CRT) followed by durvalumab as maintenance therapy prolonged progression-free survival (PFS) and overall survival (OS) in unresectable locally advanced NSCLC (LA-NSCLC). Additionally, the history of radiotherapy and CRT has been reported to increase the efficacy of PD-1 blockade in advanced NSCLC patients. We evaluated the efficacy of anti-PD-(L)1 antibody therapy after CRT failure, and how CRT changes the status of PD-L1 expression on tumors and tumor infiltrated lymphocytes (TILs) in tumor microenvironment (TME) in unresectable LA-NSCLC patients. Methods: We retrospectively reviewed unresectable LA-NSCLC patients treated with CRT between December 2007 and December 2018, and evaluated the efficacy of PD-1 blockade after CRT failure. We also analyzed PD-L1 (clone: 22C3) expression on tumor cells, and CD8 positive TILs using the paired specimens that had been obtained pre-CRT and post-CRT failure. Results: We identified 422 patients who received CRT. Median follow-up was 36.1 months (range 2.7–138.1 months). Among these patients, sixty-five patients who had progressed post-CRT received anti-PD- (L)1 therapy (PD-1 therapy: 61 patients, PD-L1 therapy: 4 patients). Response rate (RR) and PFS of anti-PD-(L)1 therapy were 48% (95% CI, 35–60) and 8.7 (95% CI, 4.5–13.0) months. The RR and PFS did not differ according to PD-L1 expression levels (Table). Of the 18 patients, 9, 7, and 2 showed upregulation in PD-L1 expression or down- or no change, respectively, post-CRT. In contrast, the density of CD8 positive TILs in TME increased by CRT treatment ([pre-CRT]: median, 110 ± 239 /mm2 vs. [post-CRT]: median, 470 ± 533 /mm2, p = 0.025). Conclusions: The clinical outcome of anti-PD-(L)1 therapy after CRT failure in LA-NSCLC patients could be better than advanced NSCLC patients, but did not differ according to PD-L1 expression levels. The efficacy of PD-(L)1 therapy enhanced by CRT treatment could be due to the infiltration of CD8 T-cells into TME. [Table: see text]

scholarly journals Neoadjuvant treatment for locally advanced unresectable and borderline resectable pancreatic cancer: oncological outcomes at a single academic centre

ESMO Open ◽  
2020 ◽  
Vol 5 (6) ◽  
pp. e000929
Author(s):  
Susana Roselló ◽  
Claudio Pizzo ◽  
Marisol Huerta ◽  
Elena Muñoz ◽  
Roberto Aliaga ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Progression Free Survival ◽  
Rank Test ◽  
Resectable Pancreatic Cancer ◽  
Borderline Resectable ◽  
Curative Intent ◽  
Kaplan Meier ◽  
Dismal Prognosis

IntroductionPancreatic cancer (PC), even in the absence of metastatic disease, has a dismal prognosis. One-third of them are borderline resectable (BRPC) or locally advanced unresectable PC (LAUPC) at diagnosis. There are limited prospective data supporting the best approach on these tumours. Neoadjuvant chemotherapy (ChT) is being increasingly used in this setting.MethodsThis is a retrospective series of consecutive patients staged as BRPC or LAUPC after discussion in the multidisciplinary board (MDB) at an academic centre. All received neoadjuvant ChT, followed by chemoradiation (ChRT) in some cases, and those achieving enough downstaging had a curative-intent surgery. Descriptive data about patient’s characteristics, neoadjuvant treatments, toxicities, curative resections, postoperative complications, pathology reports and adjuvant treatment were collected. Overall survival (OS) and progression-free survival was calculated with Kaplan-Meier method and log-rank test.ResultsBetween August 2011 and July 2019, 49 patients fulfilled the inclusion criteria, and all of them received neoadjuvant ChT. Fluorouracil+folinic acid, irinotecan and oxaliplatin was the most frequently used scheme (77%). The most prevalent grade 3 or 4 toxicities were neutropenia (26.5%), neurotoxicity (12.2%), diarrhoea (8.2%) and nausea (8.2%). 18 patients (36.7%) received ChRT thereafter. In total, 22 patients (44,9%) became potentially resectable and 19 of them had an R0 or R1 pancreatic resection. One was found to be unresectable at surgery and two refused surgery. A vascular resection was required in 7 (35%). No postoperative deaths were observed. Postoperative ChT was given to 12 (66.7%) of resected patients. Median OS of the whole cohort was 24,9 months (95% CI 14.1 to 35.7), with 30.6 months for resected and 13.1 months for non-resected patients, respectively (p<0.001).ConclusionA neoadjuvant approach in BRPC and LAUPC was well tolerated and allowed a curative resection in 38.8% of them with a potential improvement on OS.

Total neoadjuvant chemo (ctx; TNT) for locally advanced gastric cancer (GC): The Memorial Sloan Kettering Cancer Center experience.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4046-4046 ◽  
Author(s):  
Megan Greally ◽  
Vivian E. Strong ◽  
Sam S. Yoon ◽  
Daniel G. Coit ◽  
Joanne F Chou ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Subtotal Gastrectomy ◽  
Progression Free Survival ◽  
Rank Test ◽  
Cancer Center ◽  
Surgical Morbidity ◽  
Locally Advanced Gastric Cancer ◽  
Kaplan Meier ◽  
Significant Difference

4046 Background: Peri-op chemo (ctx) and surgery is a standard in the treatment of GC, based on the MAGIC (NEJM 2006; 355:11) and FLOT4 (J Clin Oncol 35:4004 [abstr]) studies. However, less than half of patients (pts) completed ctx in the MAGIC and FLOT4 studies, mainly from issues delivering post-op therapy. We assessed safety and feasibility of TNT, where all ctx is given pre-op. Methods: We reviewed GC pts who received TNT or peri-op ctx and had surgery; decision for TNT was by physician preference, based on clinical or radiographic benefit to justify completing ctx pre-op. Pt characteristics were compared using Fisher’s exact and Wilcoxon Rank Sum tests. Post-op length of stay (LOS) was calculated from date of surgery (DOS) to date of discharge and surgical morbidity was determined using the Clavien-Dindo classification. Progression free survival (PFS) and overall survival (OS) were calculated from DOS using Kaplan-Meier methods and compared between groups using the log-rank test. Results: 120 pts were identified, median age 63, 62.5% male, 98% ECOG 0/1. 93 pts (77.5%) received peri-op ctx and 27 (22.5%) received TNT. In peri-op pts, 19%, 43% and 38% received FLOT, platinum/fluropyrimidine (FP) and ECF/EOX respectively. In TNT pts, 56%, 37% and 7% received FLOT, platinum/FP and ECF/EOX respectively. 57% had subtotal gastrectomy. Surgical outcomes were similar between groups; median LOS was 6 and 7 days (p = 0.31) in peri-op and TNT pts respectively. There was no significant difference in Clavien Dindo grade I-II or III-IV morbidity between groups (p = 0.103). There were no deaths. TNT pts received higher proportions of planned treatment than peri-op ctx pts: 90% vs. 60% FP (0.001); 85% vs. 41% platinum ( < 0.001); 100% vs. 9% epirubicin (0.015) and 53% vs. 28% docetaxel (p = 0.169). At median follow-up of 19 months, median PFS and OS were not reached. There was no significant difference in PFS (p = 0.089) or OS (p = 0.59) between groups. Conclusions: TNT appears safe with no increase in post-op LOS or surgical morbidity observed. TNT pts had higher percentage drug delivery, suggesting potential benefit for administering all ctx before surgery. While longer survival follow-up is required, TNT may be considered in pts with locally advanced GC who are candidates for ctx.

Impact of adjuvant chemotherapy and cumulative cisplatin dose in locally advanced nasopharyngeal carcinoma (LA-NPC) treated with definitive chemoradiotherapy.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6046-6046
Author(s):  
Marc Oliva Bernal ◽  
Shao Hui Huang ◽  
Rachel Taylor ◽  
Jie Su ◽  
Wei Xu ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Locally Advanced ◽  
Multivariable Analysis ◽  
Stage Iv ◽  
Stage Ii ◽  
Rank Test ◽  
High Dose ◽  
Free Survival ◽  
Kaplan Meier

6046 Background: Total cumulative cisplatin dose (CDDP-D) (concurrent/induction/adjuvant) in multimodality therapy for LA-NPC has been associated with survival at centers in Asia. We evaluated the survival impact of adjuvant chemotherapy (adj chemo) and total CDDP-D in a large, single institution Canadian cohort of LA-NPC. Methods: Patients (Pts) withWHO type II and III LA-NPC treated with concurrent IMRT with high-dose CDDP and adj chemo with CDDP/Carboplatin and 5-FU (maximum total/adjuvant CDDP-D= 540/240 mg/m2) between 2003-2016 were analyzed. EBER status was tested by ISH. Staging was classified by UICC/AJCC7thedition TNM. Kaplan-Meier 5-year (5y) for overall survival (OS) and recurrence-free survival (RFS) were calculated and compared by log-rank test betweenstage, adj chemo (yes vs no) and total CDDP-D (>300 vs ≤300mg/m2). Multivariable analysis (MVA) identified survival predictors. Results: A total of 312 pts were evaluated: median age = 49.8 (range 17.4-75.9); EBER+/-/unknown=67%/1%/32%; stage II/III/IV=2%/51%/47%; T4=36%; N3=17%; adj chemo=83% (21% switched to carboplatin); median total/adjuvant CDDP-D=380/160 mg/m2; median follow-up 7.6 years (range 0.6-14.9). 5y OS differed by stage II-III vs IV (95% vs 80%, p<0.001) and total CDDP-D >300 vs ≤300mg/m2 (89% vs 83%, p=0.02). Adj chemo and total CDDP-D impacted 5y OS in stage IV (table). 5y RFS was higher in stage IV with total CDDP-D >300 vs ≤300mg/m2 (74% vs 59%, p=0.03), with a trend in locoregional control (LRC) (91% vs 80%, p=0.05) but not significant on distant control (DC) (78% vs 72%, p=0.36). Conclusions: Total CDDP-D >300 mg/m2 impacts OS in the overall cohort. The benefit of adj chemo and total CDDP-D on OS and RFS is significant in stage IV but not stage II-III LA-NPC, mainly due to higher LRC rather than DC. [Table: see text]

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