Purpose: This Phase II study was undertaken to define the efficacy and toxicity of the combination of docetaxel and irinotecan for the second-line treatment of non-small cell lung cancer (NSCLC). Patients and Methods: Forty-six patients with measurable NSCLC who had relapsed after an initial response to chemotherapy or who had failed to respond to initial chemotherapy, received 130 mg/m 2 of irinotecan IV over 90 minutes and 50 mg/m 2 docetaxel IV over 60 minutes on Day 1 q3 weeks for 6 cycles. Dexamethasone and diphenhydramine pretreatment were given. Response to treatment was evaluated by response evaluation criteria in solid tumors RECIST criteria, and toxicity was graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 2.0. Results: The most common severe (NCI CTC Grade 3+) adverse events were neutropenia (67 percent), diarrhea (28 percent), fatigue (20 percent), nausea (17 percent), infection (15 percent), vomiting (13 percent), leucopenia (13 percent), abdominal pain (11 percent), and dyspnea (11 percent). Grade 5 toxic events were seen in 2 patients. One of these 2 cases was a possibly-treatment related event (intestinal fistula). The median number of treatment cycles received was 3. Twelve patients (26 percent) received all 6 cycles of treatment. Five patients (11 percent) had a confirmed response (complete response (CR), partial response (PR), or regression). Median follow-up for the five surviving patients is 26.5 months (range: 25.1-28.4). Forty-two patients have reported progressive disease and 41 patients have died. Median time-to-progression (TTP) and survival are 2.6 months and 7.5 months, respectively. Conclusion: This second-line treatment regimen of irinotecan and docetaxel in NSCLC patients has shown activity, but can not be recommended over single-agent regimens because of significant toxicity.
Bibliographical noteFunding Information:
This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-15083, CA-63849. CA-21661, CA-25224, CA-32102, CA-21115 and CA-77440. Additional participating institutions include: Meritcare Hospitals CCOP, Fargo, ND 58122 (Preston Steen, M.D.); Sioux Community Cancer Consortium, Sioux Falls, SD 57105 (Loren K. Tschetter, M.D.); Altru Health Systems, Grand Forks, ND 58201 (Tudor Dentchev, M.D.); Rapid City Regional Oncology Group, Rapid City, SD 57709 (Larry Ebbert, M.D.); Saskatchewan Cancer Foundation; Saskatchewan Cancer Centre, Saskatoon, Saskatchewan, Canada S7N 4H4 and Allan Blair Cancer Centre, Regina, Saskatchewan, Canada S4T 7T1 ( Muhammad Salim, M.D.) The authors wish to thank Candus Bergh for data management, Janis Gjervik for protocol administration, Jennifer Frank for quality control, the Mayo E12 nursing staff for patient care and Raquel Ostby for expert secretarial assistance. Keywords: Irinotecan, Docetaxel, NSCLC, Second-line therapy Correspondence to: Alex A. Adjei, M.D., Ph.D. Division of Medical Oncology Mayo Clinic 200 First St. SW Rochester, MN 55905 USA email: firstname.lastname@example.org
- Second-line therapy