Phase II study of paclitaxel and irinotecan with intercalated gefitinib in patients with advanced non-small-cell lung cancer.
OBJECTIVE
We conducted a phase II study of combination chemotherapy with paclitaxel (Pac) and irinotecan (CPT) alternating with gefitinib (Gef) to determine the qualitative and quantitative toxicities and efficacy of this combination against advanced non-small-cell lung cancer (NSCLC).


METHODS
Patients with stage IIIB or IV NSCLC were treated with CPT at 60 mg/m2 and Pac at 160 mg/m2 on day 1 followed by Gef at 250 mg per day on days 8 to 14 every 3 weeks.


RESULTS
Between April 2005 and March 2006, 16 patients received the chemotherapy with Pac and CPT alternating with Gef. Eleven patients received 4 to 6 cycles, except for 5 patients who discontinued treatment in the second or third cycles because of disease progression in 2, grade 3 pneumonitis with pulmonary infiltration in 2, and decreased performance status in 1. Grade 3 toxicities were neutropenia, an increased glutamic pyruvic transaminase level, allergy, pneumonitis, anorexia, and fatigue. Elevation of the serum glutamic oxaloacetic transaminase level after 1 cycle was the only grade 4 toxicity. Seven of 16 patients achieved a partial response and the overall response rate in the prospective study was 43.8%. The median survival time was 18.1 months. The 1- and 2-year survival rates were 56.3% and 43.8%, respectively.


CONCLUSIONS
Pac and CPT combined with Gef was not effective enough for NSCLC.
Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan. foshita@kcch.jp
Fumihiro
F
Oshita
Haruhiro
H
Saito
Shuji
S
Murakami
Tetsuro
T
Kondo
Kouzo
K
Yamada
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D005260:Female; D000077156:Gefitinib; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D011799:Quinazolines / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome
D011799:Quinazolines; D000077146:Irinotecan; D017239:Paclitaxel; D000077156:Gefitinib; D002166:Camptothecin