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Individual Patient Data Meta-Analysis of Docetaxel Administered Once Every 3 Weeks Compared With Once Every Week Second-Line Treatment of Advanced Non–Small-Cell Lung Cancer

Massimo Di Maio, Francesco Perrone, Paolo Chiodini, Ciro Gallo, Carlos Camps, Wolfgang Schuette, Elisabeth Quoix, Chun-Ming Tsai, Cesare Gridelli

From the Clinical Trials Unit, National Cancer Institute; Department of Medicine and Public Health, Second University, Naples; Division of Medical Oncology, Azienda Ospedaliera S. Giuseppe Moscati, Avellino, Italy; Consorcio Hospital General Universitario, Valencia, Spain; Martha-Maria City Hospital Halle-Doelau, Halle, Germany; Hopital Lyautey, Strasbourg Cedex, France; and Section of Thoracic Oncology, Chest Department, Taipei Veterans General Hospital, Shih-Pai, Taipei, Taiwan

Address reprint requests to Cesare Gridelli, MD, Division of Medical Oncology, S.G. Moscati Hospital, Contrada Amoretta, 83100 Avellino, Italy; e-mail: cgridelli{at}libero.it

Purpose Although several randomized trials have been performed comparing weekly docetaxel (wD) with standard docetaxel once every 3 weeks (3wD) as second-line treatment of advanced non–small-cell lung cancer (NSCLC), no single trial had sufficient power to detect clinically relevant differences in survival.

Methods We performed a meta-analysis based on individual patient data from all identified randomized trials comparing wD with 3wD as second-line treatment of advanced NSCLC. Baseline characteristics, treatment assigned, and outcome data were collected for each patient. The primary end point was overall survival. All statistical analyses were stratified by trial.

Results Five eligible trials were identified for a total of 865 patients: 433 patients had been assigned to 3wD, and 432 patients had been assigned to wD. Median age was 62 years (range, 26 to 80 years). Performance status was 0 in 23%, 1 in 58%, and 2 in 16% of patients; 91% of the patients had received previous platinum, and 14% had received previous paclitaxel. With 733 deaths recorded (85%), median survival was 27.4 weeks for patients treated with 3wD, and 26.1 weeks for patients treated with wD (P = .24, log-rank test). There was no significant heterogeneity among the five trials. No relevant differential effect was detected in subgroup analyses. Significantly less severe and febrile neutropenia was reported with wD (P < .00001 for both), whereas no significant differences were observed for anemia, thrombocytopenia, and nonhematologic toxicity.

Conclusion wD shows similar efficacy compared with 3wD, and represents an alternative for second-line treatment of advanced NSCLC.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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