Randomized phase III trial comparing weekly docetaxel (D)-cisplatin (P) combination with triweekly D alone in elderly patients (pts) with advanced non-small cell lung cancer (NSCLC): An intergroup trial of JCOG0803/WJOG4307L.
2011; Lippincott Williams & Wilkins; Volume: 29; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2011.29.15_suppl.7509
ISSN1527-7755
AutoresTakashige Abe, Akira Yokoyama, Koji Takeda, Y. Ohe, Shoji Kudoh, Y. Ichinose, Hiroaki Okamoto, Norio Yamamoto, Hiroshige Yoshioka, Koichi Minato, Toshiyuki Sawa, Yuichiro Iwamoto, Hideo Saka, Junki Mizusawa, Taro Shibata, Shôji Nakamura, Masahiro Ando, Ken Nakagawa, N. Saijo, Tomohide Tamura,
Tópico(s)Lung Cancer Research Studies
Resumo7509 Background: Tri-weekly D is one of the standard treatment regimens for elderly advanced NSCLC pts. To investigate whether the addition of a modified platinum agent might improve the survival in these patients, we conducted a phase III trial comparing weekly DP with tri-weekly D. Methods: Eligibility criteria were: chemotherapy-naïve; unfit for bolus P administration; stage III/IV or relapsed NSCLC; age≥70; PS 0-1. Pts were randomized to receive either DP or D by the minimization method, balancing for site, age (<75/≥75), and stage (III/IV). DP comprised administration of D (20 mg/m2) and P (25 mg/m2) iv on days 1, 8, and 15 every 4 weeks. D comprised administration of D (60 mg/m2) iv on day 1 every 3 weeks. The primary endpoint was overall survival (OS). The planned sample size was 190 pts in each arm, to provide an 80% power to detect a 0.752 hazard ratio for DP to D in regard to the OS, and a 5% one-sided alpha. Results: Between Oct 2008 and Sep 2010, 276 pts were randomized (D/DP: 137/139). The first planned interim analysis was performed on 221 assessable pts (D/DP: 108/113, <75/≥75: 22/78%, male/female: 70/30%, PS 0/1: 35/65%, III/IV or relapse: 32/68%). Information time, defined as the proportion of interim events to planned events, was 24% (=73/304). The median survival times of the DP and D groups were 13.3 and 17.3 months, respectively (hazard ratio [95% CI]: 1.557 [0.976-2.485]). The predictive probability that DP would be superior to D at the time of the final analysis was 0.996%, which led to early termination of the trial. The major grade 3-4 toxicities were (%D/DP): neutropenia 88/11%, anemia 3/16%, anorexia 1/10%, febrile neutropenia 17/0%, pneumonitis 3/2%. Treatment-related death occurred in 3 pts of the DP arm. The proportion of pts with an improved symptom score (FACT-L lung symptom subscale) after 3 courses of treatment was higher in the D arm. Conclusions: This study failed to demonstrate any advantage of the addition of weekly P to single-agent D in first line chemotherapy for elderly advanced NSCLC pts.
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