A multi-centre randomized, open-label phase II trial of continuous erlotinib             plus gemcitabine or gemcitabine as first-line therapy in ECOG PS2 patients with             advanced non-small cell lung cancer.
Erlotinib and gemcitabine are active in NSCLC and have synergy in other             cancers. This study investigated the activity and tolerability of this combination             as first-line therapy in ECOG PS 2 patients. Chemotherapy-naïve patients with             NSCLC, either stage IIIB (with plural effusion) or stage IV, with measurable disease             and ECOG PS 2, and adequate organ function were randomized to receive either erlotinib             (150 mg/day p.o.) plus gemcitabine (1000 mg/m2, days 1, 8, 15, every 4 weeks)             in Arm A or gemcitabine monotherapy (Arm B). The primary end-point was progression-free             survival. Seventeen patients of a planned 120 patients were randomized (12 males;             16 Caucasians, 4 large cell, 9 adenocarcinoma; 13 former and 1 never smokers);             16 patients received treatment (8 in each arm). The incidence of treatment-related             adverse events (AEs) was 8/8 in Arm A and 6/8 in Arm B; most AEs were grade 1             or 2. The most common treatment-related non-hematological AEs were grade 1 or             2 rash (7/8) and diarrhea (7/8) in Arm A. Two patients in Arm A had partial responses,             with durations of 16 and 47 weeks, respectively. Overall disease control rate             (N=15) was 86% in Arm A versus 50% for the control arm. Erlotinib plus gemcitabine             for the treatment of ECOG 2 NSCLC patients warrants further investigation including             intermittent erlotinib regimens.
Division of Hematology and Medical Oncology, Peter MacCallum Cancer Centre, East Melbourne, Australia. michael.michael@petermac.org
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M
Michael
N
N
Pavlakis
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P
Clingan
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De Boer
M
M
Johnston
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S
Clarke
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D057239:Early Termination of Clinical Trials; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011799:Quinazolines / Q000008:administration & dosage; D012720:Severity of Illness Index; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
D011799:Quinazolines; D003841:Deoxycytidine; D000069347:Erlotinib Hydrochloride; D000093542:Gemcitabine