PMID- 19307958 OWN - NLM STAT- MEDLINE DCOM- 20091208 LR - 20181201 IS - 1537-453X (Electronic) IS - 0277-3732 (Linking) VI - 32 IP - 2 DP - 2009 Apr TI - Phase II study of epirubicin in combination with weekly docetaxel for patients with advanced NSCLC who have failed or relapsed after the frontline platinum-based chemotherapy. PG - 169-73 LID - 10.1097/COC.0b013e31817eebdc [doi] AB - BACKGROUND: We conducted a phase II study to evaluate the efficacy and toxicity of weekly docetaxel combined with epirubicin on D15 as second-line chemotherapy in Taiwanese patients with advanced non small cell lung cancer (NSCLC) who failed or relapsed after the frontline platinum-based chemotherapy. PATIENTS AND METHODS: Patients with histologically confirmed advanced NSCLC (Stage IIIB-IV) were entered into this Phase II trial. Eastern Cooperative Oncology Group performance status was 0 to 2 and adequate organ function was required. Docetaxel, 30 mg/m, was given intravenously on days 1, 8, and 15 for 30 minutes and epirubicin, 60 mg/m, was given intravenously on day 15, then following one week of rest. Treatment was repeated every 4 weeks for a maximal total of 6 cycles. RESULTS: Of the 43 eligible patients, 39 patients were evaluated for response, and all were evaluated for toxicity. The overall response rate was 11.6% [95% confidence interval (CI), 1.6-21.6%]. The median time to disease progression for all patients was 2.8 months (95% CI 1.3-4.3%). The median survival time for all patients was 7.7 months (95% CI 5.5-9.9%). The 1-year survival was 32.6% (95% CI 25.4%-39.7%). The major hematologic toxicities were neutropenia, 8/43 (19%) with grade 3-4 neutropenia, as well as anemia, 6/43 (14%) with grade 3-4 anemia. Nonhematological toxicities were modest. Fatigue was common, 77.8% in all, but only 3 (7%) patients with grade 3-4 toxicities. Diarrhea was also common but not severe, 7/43 (16%) with grade 1-2 episodes, and 1/43 (2%) with grade 3-4 episodes. Nail changes, peripheral edema, lacrimation, and alopecia were mild. Hepatic and renal impairment was also only mild. CONCLUSION: Combining weekly doses of docetaxel 30 mg/m with epirubicin 60 mg/m on D15 was not shown to improve both efficacy and tolerability for advanced NSCLC patients who have relapsed disease after frontline platinum-based chemotherapy. FAU - Lin, Chih-Ming AU - Lin CM AD - Department of Internal Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan. FAU - Chen, Chih-Hung AU - Chen CH FAU - Chang, John W C AU - Chang JW FAU - Tsao, Thomas C Y AU - Tsao TC LA - eng PT - Clinical Trial, Phase II PT - Journal Article PL - United States TA - Am J Clin Oncol JT - American journal of clinical oncology JID - 8207754 RN - 0 (Taxoids) RN - 15H5577CQD (Docetaxel) RN - 3Z8479ZZ5X (Epirubicin) SB - IM MH - Adenocarcinoma/*drug therapy/pathology MH - Adult MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology MH - Carcinoma, Squamous Cell/*drug therapy/pathology MH - Docetaxel MH - Epirubicin/administration & dosage MH - Female MH - Humans MH - Lung Neoplasms/*drug therapy/pathology MH - Male MH - Middle Aged MH - Neoplasm Recurrence, Local/diagnosis MH - Neoplasm Staging MH - Prognosis MH - Salvage Therapy MH - Survival Rate MH - Taxoids/administration & dosage MH - Treatment Failure EDAT- 2009/03/25 09:00 MHDA- 2009/12/16 06:00 CRDT- 2009/03/25 09:00 PHST- 2009/03/25 09:00 [entrez] PHST- 2009/03/25 09:00 [pubmed] PHST- 2009/12/16 06:00 [medline] AID - 00000421-200904000-00012 [pii] AID - 10.1097/COC.0b013e31817eebdc [doi] PST - ppublish SO - Am J Clin Oncol. 2009 Apr;32(2):169-73. doi: 10.1097/COC.0b013e31817eebdc.