A Phase II Study of Weekly Irinotecan and Capecitabine in Patients with Previously Treated Non-Small Cell Lung Cancer

• Published in: Clinical cancer research 2003-12, Vol.9 (16), p.5909-5914
• Main Authors: HAN, Ji-Youn, DAE HO LEE, HYAE YOUNG KIM, KIM, Eun-A, JAE JIN LEE, SO YOUNG JU, EUN HEE SHIN, JIN SOO LEE
• Format: Article
• Language: English
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - secondary; Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Camptothecin - administration & dosage; Camptothecin - analogs & derivatives; Capecitabine; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - secondary; Chemotherapy; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Disease Progression; Female; Fluorouracil - analogs & derivatives; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Medical sciences; Middle Aged; Neoplasm Staging; Pharmacology. Drug treatments; Salvage Therapy; Survival Rate; Treatment Outcome
• ISSN: 1078-0432; 1557-3265

Purpose: Irinotecan and capecitabine have synergistic antitumor activity with distinct mechanisms of action but without overlapping major toxicity. We conducted a Phase II study to evaluate the efficacy of weekly irinotecan plus capecitabine in patients with previously treated non-small cell lung cancer (NSCLC). Experimental Design: Eligible patients had received at least one prior chemotherapy regimen. The treatment consisted of irinotecan (90–100 mg/m 2 i.v.) on days 1 and 8 plus capecitabine (1000 mg/m 2 p.o. b.i.d.) on days 1–14 of a 21-day cycle. Treatment was given until disease progression or unacceptable toxicity Results: Thirty-seven patients with median age of 59 years were enrolled. Eighteen (49%) patients had received one prior regimen, and 19 (51%) patients had received two or more prior regimens. The Initial 5 patients received 100 mg/m 2 irinotecan with grade 3 diarrhea seen in 3 of 5 patients, and subsequent 32 patients received 90 mg/m 2 irinotecan. Four (11.4%) of 35 evaluable patients had partial response and 12 (34.3%) had stable disease. There was no complete response. All responses were noted in patients who had received one prior regimen (4 of 18, 22%), but there was no response among the patients who had received two or more regimens. Median duration of response was 5.6 months (range, 5–8.7 months). At a median follow-up of 6 months, median survival was 7.4 months (95% confidence interval, 3.6–9.0). Grade 3 or 4 toxicities were neutropenia (12%), anemia (13%), and diarrhea (12%) at the dose level of 90 mg/m 2 . Conclusions: Weekly irinotecan plus capecitabine had favorable antitumor activity and toxicity profile as a second-line treatment for recurrent NSCLC. This regimen may provide an additional treatment option for patients with advanced NSCLC.