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Chemoradiotherapy with or without AE-941 in stage III non-small cell lung cancer: a randomized phase III trial.

ABSTRACT: BACKGROUND AE-941 is a standardized aqueous shark cartilage extract with antiangiogenic properties that has previously been evaluated in phase I and II clinical trials. Our objective was to determine the effect of adding AE-941 to chemoradiotherapy on overall survival of patients with unresectable stage III non-small cell lung cancer (NSCLC). METHODS A randomized, double-blinded, placebo-controlled, phase III clinical trial was designed to test the efficacy of AE-941 in unresectable stage III NSCLC patients who were treated with chemoradiotherapy. Between June 5, 2000, and February 6, 2006, 379 eligible patients were enrolled in community and academic oncology centers across the United States and Canada. In February 2006, the trial was closed to new patient entry before meeting the target sample size because of insufficient accrual. All subjects received induction chemotherapy followed by concurrent chemotherapy with chest radiotherapy. Each participating center administered one of the two chemotherapy regimens, either carboplatin and paclitaxel, or cisplatin and vinorelbine. The primary endpoint was overall survival, and secondary endpoints were time to progression, progression-free survival, tumor response rate, and toxic effects. Event-time distributions were estimated by the Kaplan-Meier method. All statistical tests were two-sided. RESULTS There was no statistically significant difference in overall survival between the chemoradiotherapy plus AE-941 group (n = 188; median survival = 14.4 months, 95% confidence interval = 12.6 to 17.9 months) and the chemoradiotherapy plus placebo group (n = 191; median survival = 15.6 months, 95% confidence interval = 13.8 to 18.1 months) (P = .73). Time to progression, progression-free survival, and tumor response rates were not statistically significantly different between the AE-941 and the placebo groups. No differences between the two groups were observed in common grade 3 or higher toxic effects attributable to chemoradiotherapy. CONCLUSIONS The addition of AE-941 to chemoradiotherapy did not improve overall survival in patients with unresectable stage III NSCLC. This study does not support the use of shark cartilage-derived products as therapy for lung cancer.

SUBMITTER: Lu C

PROVIDER: S-EPMC2902826 | biostudies-literature | 2010 Jun

REPOSITORIES: biostudies-literature

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Chemoradiotherapy with or without AE-941 in stage III non-small cell lung cancer: a randomized phase III trial.

Lu Charles C Lee J Jack JJ Komaki Ritsuko R Herbst Roy S RS Feng Lei L Evans William K WK Choy Hak H Desjardins Pierre P Esparaz Benjamin T BT Truong Mylene T MT Saxman Scott S Kelaghan Joseph J Bleyer Archie A Fisch Michael J MJ

Journal of the National Cancer Institute 20100526 12

BACKGROUND AE-941 is a standardized aqueous shark cartilage extract with antiangiogenic properties that has previously been evaluated in phase I and II clinical trials. Our objective was to determine the effect of adding AE-941 to chemoradiotherapy on overall survival of patients with unresectable stage III non-small cell lung cancer (NSCLC). METHODS A randomized, double-blinded, placebo-controlled, phase III clinical trial was designed to test the efficacy of AE-941 in unresectable stage III NS ...[more]

PMID: 20505152

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Project description:ImportanceThere is limited evidence to guide stage I to II small cell lung cancer (SCLC) treatment.ObjectiveTo examine the characteristics and outcomes among patients with stage I to II SCLC treated with modern chemoradiotherapy.Design, setting, and participantsIn this post hoc secondary analysis of the Concurrent Once-Daily vs Twice-Daily Radiotherapy Trial (CONVERT), a multicenter phase 3 trial conducted in patients with limited-stage SCLC from April 7, 2008, to November 29, 2013, patients with TNM stage I to II SCLC were compared with those with stage III disease. Data analysis was performed from November 1, 2017, to February 28, 2018.InterventionsIn CONVERT, patients were randomized to receive twice-daily (45 Gy in 30 fractions) or once-daily (66 Gy in 33 fractions) chemoradiotherapy. Prophylactic cranial irradiation (PCI) was offered, if indicated.Main outcomes and measuresThe primary trial end point was overall survival (OS). TNM staging information was collected prospectively; this was an unplanned analysis because stratification was not performed according to TNM stage.ResultsA total of 509 (277 [54.4%] men; mean [SD] age, 61.5 [8.3] years) of 543 patients (93.7%) with TNM staging information were eligible for this subgroup analysis, and 86 of the 509 (16.9%) had TNM stage I to II disease. The median gross tumor volume was smaller in patients with stage I to II disease (38.4 cm3; range, 2.2-593.0 cm3) compared with patients with stage III disease (93 cm3; range, 0.5-513.4 cm3) (P < .001). No other significant differences were found in baseline and treatment characteristics and chemoradiotherapy adherence between the 2 groups or the number of patients with stage I to II disease (78 [90.7%]) and stage III disease (346 [81.8%]) who received PCI (P = .10). Patients with stage I to II disease achieved longer OS (median, 50 months [95% CI, 38 to not reached months] vs 25 months [95% CI, 21-29 months]; hazard ratio, 0.60 [95% CI, 0.44-0.83]; P = .001) compared with patients with stage III disease. In patients with stage I to II disease, no significant survival difference was found between the trial arms (median, 39 months in the once-daily arm vs 72 months in the twice-daily arm; P = .38). Apart from lower incidence of acute esophagitis in patients with stage I to II disease compared with patients with stage III disease (grade ≥3, 9 [11.3%] vs 82 [21.1%]; P < .001), the incidences of acute and late toxic effects were not significantly different.Conclusions and relevancePatients with stage I to II SCLC in CONVERT achieved long-term survival with acceptable toxic effects after chemoradiotherapy and PCI. This study suggests that patients with stage I to II small cell lung cancer treated with modern chemoradiotherapy have better outcomes compared with patients with stage III disease, providing information that practitioners can potentially give their patients to aid clinical decisions.Trial registrationClinicalTrials.gov identifier: NCT00433563.

Dataset Information

Chemoradiotherapy with or without AE-941 in stage III non-small cell lung cancer: a randomized phase III trial.

Publications

Chemoradiotherapy with or without AE-941 in stage III non-small cell lung cancer: a randomized phase III trial.

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