scholarly journals Sintilimab With Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Squamous Non-small-cell Lung Cancer: Real-world Data Study

2021 ◽  
Author(s):  
Xinqing Lin ◽  
Haiyi Deng ◽  
Suyang Li ◽  
Xiaohong Xie ◽  
Chao Chen ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Real Life ◽  
Small Cell ◽  
Small Cell Lung ◽  
Real World Data ◽  
Clinical Benefits ◽  
Grade 3

Abstract Purpose:The ORIENT-12 study demonstrated the promising results of sintilimab combined with gemcitabine and platinum (GP) therapy in squamous non-small-cell lung cancer (sqNSCLC) patients. However, the efficacy of sintilimab plus paclitaxel/nab-paclitaxel and platinum (TP) in sqNSCLC is not yet known. Methods: Real-life data were collected from patients with untreated locally advanced or metastatic sqNSCLC who were treated with sintilimab plus TP (arm A) or sintilimab plus GP (arm B) between January 2019 and January 2021. Results:A total of 52 patients were included (arm A, n=32 and arm B, n=20). After a median follow-up of 12.1 months, the median PFS was 10.9 months (95% confidence interval [CI], 5.0 to 16.7) in arm A and 7.5 months (95% CI, 4.0–10.9) in arm B (hazard ratio [HR], 0.64; 95% CI, 0.30 to 1.4; P = 0.24). The median overall survival was 20.1 months (95% CI, 13.6 to 26.6) in arm A and 16.3 months (95% CI, 2.9 to 29.6) in arm B (HR, 0.69; 95% CI, 0.26–1.84; P = 0.46). The overall response rate was 59.4% in arm A and 40.0% in arm B. Adverse events of grade 3 or higher occurred in 37.5% of the patients in arm A and 55.0% of the patients in arm B. Conclusions: Sintilimab-TP exhibits similar clinical benefits compared with sintilimab-GP in patients with untreated advanced or metastatic sqNSCLC.

Randomized phase Ⅱ trial of uracil/tegafur and cisplatin versus pemetrexed and cisplatin with concurrent thoracic radiotherapy for locally advanced unresectable stage Ⅲ non-squamous non-small-cell lung cancer: NJLCG1001.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8527-8527
Author(s):  
Kana Watanabe ◽  
Yukihiro Toi ◽  
Atsushi Nakamura ◽  
Tatsuro Fukuhara ◽  
Ryosuke Chiba ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Objective Response ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Grade 3 ◽  
Involved Field

8527 Background: It is unknown which regimen is the best in concurrent chemoradiotherapy (CCRT) of locally advanced non-squamous non-small cell lung cancer (NSCLC). Our previous randomized phase Ⅱ study, NJLCG0601, showed that chemoradiotherapy with uracil/tegafur (UFT) and cisplatin achieved promising efficacy with acceptable toxicities. In this trial, this regimen was compared to a regimen with pemetrexed and cisplatin for stage Ⅲ non-squamous NSCLC. Methods: Patients with inoperable stage Ⅲ non-squamous NSCLC were randomized to UFT 400 mg/m2 on days 1–14 and 29–42, and cisplatin 80 mg/m2 on days 8 and 36 (UP), or pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on days 1, 22, and 43 (PP). Involved-field radiotherapy (IFRT) was administered from day 1 to a total dose of 66 Gy radiotherapy in 33 fractions. Consolidation chemotherapy after CCRT was not planned for this study. The primary endpoint was 2-year overall survival (OS), with expected rates of 55% and a lower limit of 35% (alfa 0.05, beta 0.2). Secondary endpoints were the objective response rate (ORR), progression-free survival (PFS), OS, and toxicity profile. Results: From November 2010 to June 2017, 86 patients were enrolled from 11 institutions. Of the 85 eligible patients, the rate of 2-year OS was 78.6% (95% CI: 62.8–88.3%) in the UP arm and 85.5% (95% CI: 70.5–93.2%) in the PP arm. The ORR was 76.7% in the UP arm and 81.0% in the PP arm. With a median follow-up of 54 months, median PFS and OS were 12.3 and 64.2 months in the UP arm, and 26.2 months and not reached in the PP arm, respectively. Grade 3/4 febrile neutropenia was more frequent in the UP arm than in the PP arm (14.0%, 2.0%, respectively). Grade 3/4 pneumonitis occurred in 7.0% and 4.8% of patients in UP and PP arms, respectively. Conclusions: Both regimens with IFRT achieved the expected 2-year survival rate. PP had more favorable results than UP in terms of OS and PFS. We selected the PP arm for the next step.

Radiation pneumonitis in patients with locally advanced non-small cell lung cancer treated with concurrent radiotherapy and gemcitabine after induction with gemcitabine and carboplatin

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e18504-e18504
Author(s):  
R. M. Michel ◽  
D. Gallardo-Rincon ◽  
C. Villarreal-Garza ◽  
A. Astorga-Ramos ◽  
J. Zamora ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Radiation Pneumonitis ◽  
Locally Advanced ◽  
Disease Patient ◽  
Small Cell ◽  
Small Cell Lung ◽  
Thoracic Radiation ◽  
Grade 3

e18504 Background: The combination of chemotherapy (CT) and thoracic radiation (RT) is the standard treatment for locally advanced non-small cell lung cancer (NSCLC). The most favorable CT regime, timing of full-dose CT and the best way to combine CT with RT to maximize systemic and radiosensitizing effects remain to be determined. The aim of this study was to assess the efficacy, safety and tolerability of gemcitabine concurrent with RT after induction CT (gemcitabine + carboplatin) in locally advanced NSCLC. Methods: Patients with histologically proven NSCLC IIIA and IIIB received carboplatin (AUC of 2.5) and gemcitabine (800 mg/m2) on day 1 and 8, every 21 days (two cycles), followed by conventional fractioned RT (60Gy) with concomitant weekly gemcitabine 200 mg/m2 and by consolidation CT. Survival was analyzed with Kaplan-Meier. Results: Median follow-up was of 11.9 months, 11 patients (57.9%) had stage IIIB disease. Patient inclusion was discontinued due to high grade 3/4 radiation pneumonitis events (5/19 patients, 26.3%). One treatment-related death from radiation pneumonitis occurred. The most common hematological side effects grade 3/4 were anemia and neutropenia 3/19 (15.8%) each and thrombocytopenia 4/19 (21.1%) during induction CT. Partial response was observed in 11 patients (57.9%) following induction. After concurrent chemo-radiotherapy, overall response was 68.4%. Four patients underwent surgical resection. Median progression-free survival was 12 ± 1 months (95% CI, 9.8 -14.1). Overall survival was of 21 ± 3.5 months (95% CI, 14–27.9). Conclusions: Concurrent RT with gemcitabine after induction CT with gemcitabine and carboplatin showed a high response rate. However, it is associated with excessive pulmonary toxicity. Adjustments in gemcitabine dosage during RT or changes in RT planning could reduce toxicity. No significant financial relationships to disclose.

Immune-related toxicities in non-small cell lung cancer: Real-life predictors of outcome to checkpoint inhibitors?

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14135-e14135
Author(s):  
Emanuela Romano ◽  
Roberta Poli ◽  
Clement Dumont ◽  
Lisa Pietrogiovanna ◽  
Marie Vigan ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Checkpoint Inhibitors ◽  
Locally Advanced ◽  
Real Life ◽  
Progression Free Survival ◽  
Small Cell ◽  
Small Cell Lung ◽  
Dermatologic Toxicity

e14135 Background: Immune checkpoint inhibitors (ICIs) are approved for the treatment of non-small cell lung cancer (NSCLC) and are associated with immune-related adverse events (irAEs). However, real-life data on type, occurrence and kinetics of irAEs, and their predictive value on treatment outcome are lacking. Here, we report on the relation between irAEs, including endocrine irAEs, and outcome to anti-PD-/L-1 (programmed cell death protein-/ligand-1) ICIs. Methods: A total of 147 patients (pts), with locally advanced/metastatic NSCLC, treated with anti-PD-1 (N 140; 95%) or anti-PD-L1 agents (N 7; 5%) as ≥ 2 line treatment were included in two independent, prospective, cohorts at the Institut Curie (ALCINA-NCT02866149) and at Biella Hospital (Italy). PD-L1 status was assessed by immunohistochemistry (clone 22C3, Dako). Progression-free survival (PFS) and overall survival (OS) were estimated with Kaplan-Meier curves. Results: Median follow-up of 147 pts was 10.2 (range: 0.7-42.8) months; median age, 66 (35-85) years; 100 men (68%). After treatment initiation, irAEs were observed in 72 pts (49%). Thirty one (43%) pts had only endocrine irAEs, mostly thyroid dysfunctions (N 44, 61%). Pre-existing thyroid disease was present in only 6 pts (4%). Dermatologic toxicity in 21 (29%) pts was the next most frequent irAE, 22 (30%) pts had other types of irAEs. Among patients with irAEs, 61 (85%) had ≤ 2 coexisting irAEs, and 13 (18%) pts had > 2 irAEs. Most irAEs were G1 (63%) and G2 (18%). Onset and kinetics differed according to irAE type. There was no association between PD-L1 status and irAE occurrence. Median PFS was 7.2 and 4.2 months in irAEs vs no-irAEs group, respectively [HR 0.70 (95% CI 0.46;1.08), p 0.11]. Median OS in the irAEs group was 18.1 months vs 13.6 months no-irAEs group [HR 0.64 (95% CI 0.37;0.98), p 0.039]. Median OS in the endocrine-irAEs group was 23.5 vs 13.6 months in the no-irAEs group [HR 0.58 (0.74;3.92), p 0.2]. Conclusions: In this study, we show that irAEs – including endocrine type – are frequent in NSCLC pts treated with ICIs and that their occurrence is associated with a survival benefit.

Updated survival date of phase I/II study of carboplatin plus nab-paclitaxel and concurrent radiotherapy for patients with locally advanced non-small cell lung cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8529-8529
Author(s):  
Atsushi Horiike ◽  
Yuko Kawano ◽  
Tomonari Sasaki ◽  
Hiroyuki Yamaguchi ◽  
Katsuya Hirano ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Cell Lung Cancer ◽  
Performance Status ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung ◽  
Concurrent Radiotherapy ◽  
Grade 3

8529 Background: Chemoradiation regimens of greater efficacy are needed for patients with locally advanced non–small cell lung cancer (NSCLC). Methods: Patients between 20 and 74 years of age with unresectable NSCLC of stage IIIA or IIIB and a performance status of 0 or 1 were eligible for the study. In the phase II part of the study, patients received weekly nab-paclitaxel at 50 mg/m2 together with weekly carboplatin at an area under the curve (AUC) of 2 mg mL–1 min and concurrent radiotherapy with 60 Gy in 30 fractions. This concurrent phase was followed by a consolidation phase consisting of two 3-week cycles of nab-paclitaxel plus carboplatin. The primary end point of the phase II part of the study was progression-free survival (PFS). Results: Between October 2014 and November 2016, 58 patients were enrolled at 14 institutions in Japan, with 56 of these individuals being evaluable for treatment efficacy and safety. At the median follow-up time of 26.0 months (range, 4.0 to 49.6 months), the median overall survival (OS) was not reached (95% confidence interval [CI], 25.3 months to not reached) and the 2-year OS rate was 66.1% (95% CI, 52.1% to 76.8 %). The median PFS was 11.8 months (60% CI, 10.6 to 16.8 months; 95% CI, 8.2 to 21.0 months). The overall response rate was 76.8% (95% CI, 64.2% to 85.9%), and the disease control rate was 94.6% (95% CI, 85.4% to 98.2%). Subgroup analysis according to histology or age revealed no significant differences in median PFS or OS. Common toxicities of grade 3 or 4 in the concurrent phase included leukopenia (60.7%) and neutropenia (28.6%). Pneumonitis of grade 3 was observed in two patients during the study period. No treatment-related deaths occurred. Conclusions: Our results reveal encouraging feasibility and activity for concurrent chemoradiation with nab-paclitaxel at 50 mg/m2 and carboplatin at an AUC of 2 mg mL–1 min in patients with locally advanced NSCLC. Clinical trial information: UMIN000012719.

scholarly journals Anlotinib for refractory advanced non-small-cell lung cancer: A systematic review and meta-analysis

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0242982
Author(s):  
Guocan Yu ◽  
Yanqin Shen ◽  
Xudong Xu ◽  
Fangming Zhong
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Advanced Nsclc ◽  
Meta Analysis ◽  
Small Cell ◽  
Small Cell Lung ◽  
Hazard Ratios ◽  
Clinical Benefits ◽  
Grade 3

Objective To assess the efficacy and toxicity of anlotinib for the treatment of refractory advanced non-small-cell lung cancer (NSCLC). Methods We systematically searched databases for randomized controlled trials on anlotinib treatment for patients with advanced NSCLC published until November 6, 2020. Articles were assessed and data were extracted independently by two investigators. Further, we analyzed hazard ratios (HRs) for progression-free and overall survival (PFS and OS, respectively). In addition, we analyzed risk ratio (RR) for overall response and disease control rates (ORR and DCR, respectively) and the odds ratio (OR) for the main adverse events (AEs) using RevMan 5.3 software. Results This analysis included 594 patients from three clinical studies. The pooled HRs for PFS and OS were 0.27 (95% confidence interval (CI): 0.22–0.33, P < 0.001) and 0.68 (95% CI: 0.56–0.83, P < 0.001), respectively, indicating that anlotinib administration significantly improved PFS and OS in patients with advanced NSCLC. The pooled RRs for ORR and DCR were 11.62 (95% CI: 2.75–49.14, P < 0.001) and 2.30 (95% CI: 1.91–2.77, P < 0.001), respectively, indicating that anlotinib administration in patients with advanced NSCLC improved ORR and DCR. The pooled OR for AEs of grade 3 or higher was 2.94 (95% CI: 1.99–4.35, P < 0.001), indicating that AEs of grade 3 or higher were more prevalent in the anlotinib group than in the placebo group. Conclusion Anlotinib, an effective choice of third- or later line therapy for patients with refractory advanced NSCLC, provides clinical benefits in terms of PFS, OS, ORR, and DCR. AEs associated with anlotinib were tolerable.

scholarly journals Randomized Phase III Study of Thoracic Radiation in Combination With Paclitaxel and Carboplatin With or Without Thalidomide in Patients With Stage III Non–Small-Cell Lung Cancer: The ECOG 3598 Study

2012 ◽  
Vol 30 (6) ◽  
pp. 616-622 ◽  
Author(s):  
Tien Hoang ◽  
Suzanne E. Dahlberg ◽  
Joan H. Schiller ◽  
Minesh P. Mehta ◽  
Thomas J. Fitzgerald ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Small Cell ◽  
Phase Iii ◽  
Stage Iii ◽  
Small Cell Lung ◽  
Thoracic Radiation ◽  
Grade 3

Purpose The primary objective of this study was to compare the survival of patients with unresectable stage III non–small-cell lung cancer (NSCLC) treated with combined chemoradiotherapy with or without thalidomide. Patients and Methods Patients were randomly assigned to the control arm (PC) involving two cycles of induction paclitaxel 225 mg/m2 and carboplatin area under the curve (AUC) 6 followed by 60 Gy thoracic radiation administered concurrently with weekly paclitaxel 45 mg/m2 and carboplatin AUC 2, or to the experimental arm (TPC), receiving the same treatment in combination with thalidomide at a starting dose of 200 mg daily. The protocol allowed an increase in thalidomide dose up to 1,000 mg daily based on patient tolerability. Results A total of 546 patients were eligible, including 275 in the PC arm and 271 in the TPC arm. Median overall survival, progression-free survival, and overall response rate were 15.3 months, 7.4 months, and 35.0%, respectively, for patients in the PC arm, in comparison with 16.0 months (P = .99), 7.8 months (P = .96), and 38.2% (P = .47), respectively, for patients in the TPC arm. Overall, there was higher incidence of grade 3 toxicities in patients treated with thalidomide. Several grade 3 or higher events were observed more often in the TPC arm, including thromboembolism, fatigue, depressed consciousness, dizziness, sensory neuropathy, tremor, constipation, dyspnea, hypoxia, hypokalemia, rash, and edema. Low-dose aspirin did not reduce the thromboembolic rate. Conclusion The addition of thalidomide to chemoradiotherapy increased toxicities but did not improve survival in patients with locally advanced NSCLC.

Single institution toxicity of definitive chemoradiation and maintenance durvalumab in locally advanced non-small cell lung cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e20554-e20554
Author(s):  
Pranitha Prodduturvar ◽  
Konstantinos Leventakos ◽  
Ashley Potter ◽  
Robert W. Gao ◽  
Anastasios Dimou ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Real World ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung ◽  
The Real ◽  
The Pacific ◽  
Grade 3

e20554 Background: The paradigm for locally advanced non-small cell lung cancer has been markedly altered to include maintenance durvalumab (D) post completion of definitive chemoradiation (CRT) following the publication of the Pacific trial in 2018. The toxicity of this treatment has not been well evaluated in the real-world setting. Methods: We identified 42 patients (pts) with Stage IIB-IIIC NSCLC treated at Mayo Clinic Rochester between 6/1/2018 and 10/1/2020 who received definitive CRT followed by maintenance D. Data were abstracted by retrospective chart review under an IRB approved protocol. Results: Median age was 66 yrs (range 47-90) and 62% were women. Primary lung cancer histology included 19 adenocarcinoma, 20 squamous cell, and 3 adenosquamous. The distribution of stages was: IIB (4/42), IIIA (15/42), IIIB (19/42), IIIC (4/42). Approximately half of patients had PDL1 expression > 25% (20/42). With a median follow up of 12.2 months (calculated from first cycle of D; range 4.2-30.5 months), 14 had completed one year of maintenance D, 16 were receiving ongoing D, and 10 stopped D early with 6/12 discontinuing due to disease progression (4/6 local progression, 2/6 distant progression). Other reasons for discontinuation (5/10) included grade 3 colitis, grade 2 hepatitis, aspergillus lung infection, and flare of autoimmune disorders. One quarter of patients experienced grade 2 radiation pneumonitis (RP; 10/42) with median time to development of RP 78 days from end of CRT and 45 days from start of D. RP was determined by multidisciplinary review of imaging and treatment fields. 17/42 patients developed immune related adverse events (see Table for details). There was minimal overlap between the patients who experienced pneumonitis and immune related toxicity; 2/17 had both pneumonitis and immune related toxicity (hepatitis, thyroiditis). Conclusions: In our early experience with the Pacific regimen, 29% of patients did not complete D due to either toxicity or progression during D administration. Pneumonitis was common (10/42 patients) although there were no grade 3 events. Nearly half of the patients developed an immune-related adverse event. Further analysis is needed to evaluate the real-world toxicity of this treatment as well as oncologic outcomes.[Table: see text]

First-line anlotinib-based combination treatment for patients with advanced non-small cell lung cancer: A three arms, prospective study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21073-e21073
Author(s):  
Baohui Han ◽  
Tianqing Chu ◽  
Wei Zhang ◽  
Bo Zhang ◽  
Xueyan Zhang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung ◽  
First Line ◽  
Common Grade ◽  
Grade 3 ◽  
Egfr Mutated

e21073 Background: Anlotinib, a multi-target tyrosine kinase inhibitor antiangiogenic drug, had been recommended by guideline for the 3 lines or more treatment of non-small cell lung cancer (NSCLC) in China. However, data of anlotinib based combination in the first-line treatment remains unknown. Therefore, this study aims to evaluate efficacy and safety of the combination of erlotinib, chemotherapy or sintilimab with anlotinib respectively, in Chinese patients with locally advanced or metastatic NSCLC. Methods: In this open-label, three arms, prospective study, locally advanced or metastatic NSCLC patients with EGFR mutation (exon 19 deletion or L858R) (Cohort A) receive anlotinib (10 mg QD from day 1 to 14 of a 21-day cycle) and erlotinib (150 mg once daily) until disease progression or treatment intolerance. For patients with EGFR mutation negative, the treatment regimen was anlotinib (12 mg QD from day 1 to 14 of a 21-day cycle) in combination with chemotherapy (Cohort B) or sintilimab (Cohort C) according to investigator. The primary outcome was objective response (ORR), the secondary outcomes were progression free survival (PFS), disease control rate (DCR), overall survival (OS) and safety. Results: A total of 80 patients were enrolled with 30 patients in Cohort A, 28 patients in Cohort B, and 22 patients in Cohort C. Among these patients, 16 (57.1%), 7 (23.3%) and 1(4.5%) were female in Cohort A, B, and C, respectively. And 9 (32.1%) and 4 (18.2%) of them had brain metastasis in Cohort A and C, respectively. Till December 2020, all the patients received tumor assessment at least once. In Cohort A, 26 patients achieved confirmed PR, the ORR was 92.9%, and DCR was 96.4%. Median PFS was 20.53 months, and the 12-month PFS rate was 81.5%. In Cohort B, 17 patients achieved PR, the ORR was 60.0%, while DCR was 96.7%. Median PFS was 13.3 months, and the 12-month PFS rate was 55.5%. In Cohort C, medium PFS was 15.6 months. The 18- and 24-month PFS rate was 45.9% and 26.2%, respectively. The most common grade 3 adverse events (AEs) were rash (17.2%), oral mucositis (10.3%), diarrhea (6.9%) and proteinuria (6.9%) in Cohort A, and a grade 4 hypertension was observed. In Cohort B, the most common grade 3 AEs were platelet count decreased (20.0%), leucopenia (16.7%), hand-foot-skin reaction (10.0%), hypertriglyceridemia (10.0%), oral mucositis (6.7%) and thrombus (6.7%). Grade 4 platelet count decreased occurred in three patients (10.0%). Safety data of Cohort C had been published elsewhere. Conclusions: This study suggest that anlotinib-based combination treatment for patients with advanced non-small cell lung cancer might be new first-line therapy strategy. For EGFR-mutated positive patients, anlotinib plus erlotinib shows good efficacy and well tolerability. For EGFR-mutated negative patients, anlotinib combines with chemotherapy or sintilimab also may be a promising first-line treatment. Clinical trial information: NCT03628521.

Treatment strategies for unresectable locally advanced non-small cell lung cancer in the real-life ESME cohort

Lung Cancer ◽  
2021 ◽  
Author(s):  
Nicolas Girard ◽  
Maurice Perol ◽  
Gaëtane Simon ◽  
Clarisse Audigier Valette ◽  
Radj Gervais ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Locally Advanced ◽  
Real Life ◽  
Treatment Strategies ◽  
Small Cell ◽  
Small Cell Lung ◽  
The Real

Phase III Trial Comparing Docetaxel and Cisplatin Combination Chemotherapy With Mitomycin, Vindesine, and Cisplatin Combination Chemotherapy With Concurrent Thoracic Radiotherapy in Locally Advanced Non–Small-Cell Lung Cancer: OLCSG 0007

2010 ◽  
Vol 28 (20) ◽  
pp. 3299-3306 ◽  
Author(s):  
Yoshihiko Segawa ◽  
Katsuyuki Kiura ◽  
Nagio Takigawa ◽  
Haruhito Kamei ◽  
Shingo Harita ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Combination Chemotherapy ◽  
Locally Advanced ◽  
Small Cell ◽  
Phase Iii ◽  
Thoracic Radiotherapy ◽  
Small Cell Lung ◽  
Grade 3

Purpose To demonstrate the efficacy of docetaxel and cisplatin (DP) chemotherapy with concurrent thoracic radiotherapy (TRT) for patients with locally advanced non–small-cell lung cancer (LA-NSCLC). Patients and Methods Patients age 75 years or younger with LA-NSCLC, stratified by performance status, stage, and institution, were randomly assigned to two arms consisting of DP (docetaxel 40 mg/m2 and cisplatin 40 mg/m2 on days 1, 8, 29, and 36) or mitomycin, vindesine, and cisplatin (MVP) chemotherapy with concurrent TRT. Results Between July 2000 and July 2005, 200 patients were allocated into either the DP or MVP arm. The survival time at 2 years, a primary end point, was favorable to the DP arm (P = .059 by a stratified log-rank test as a planned analysis and P = .044 by an early-period, weighted log-rank as an unplanned analysis). There was a trend toward improved response rate, 2-year survival rate, median progression-free time, and median survival in the DP arm (78.8%, 60.3%,13.4 months, and 26.8 months, respectively) compared with the MVP arm (70.3%, 48.1%, 10.5 months, and 23.7 months, respectively), which was not statistically significant (P > .05). Grade 3 febrile neutropenia occurred more often in the MVP arm than in the DP arm (39% v 22%, respectively; P = .012), and grade 3 to 4 radiation esophagitis was likely to be more common in the DP arm than in the MVP arm (14% v 6%, P = .056). Conclusion DP chemotherapy combined with concurrent TRT is an alternative to MVP chemotherapy for patients with LA-NSCLC.

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