PMID- 26680950 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20151219 LR - 20151218 IS - 1598-2998 (Print) IS - 1598-2998 (Linking) VI - 35 IP - 4 DP - 2003 Aug TI - Phase II Study of Gemcitabine and Vinorelbine as Second-Line Chemotherapy in Non-Small Cell Lung Cancer. PG - 294-8 LID - 10.4143/crt.2003.35.4.294 [doi] AB - PURPOSE: With the increased use of chemotherapy for non small cell lung cancer (NSCLC), a growing group of patients can now be considered for second-line chemotherapy. However, guidelines for the second line treatment remain to be developed. The objective of this study was to evaluate the efficacy and safety of the gemcitabine and vinorelbine combination therapy in patients with advanced NSCLC, pretreated with taxane and platinum based regimens. Gemcitabine has already demonstrated activity in this patient group, with the combination therapy having been reported to be well tolerated in previous phase I/II studies. MATERIALS AND METHODS: Forty two patients with advanced NSCLC (stages III/IV), having received prior taxane and platinum based chemotherapy, with an ECOG performance status (PS) 0~2, and unimpaired hematopoietic and organ function, were treated with vinorelbine, 20 mg/m2, followed by gemcitabine, 1, 000 mg/m2, both administered on days 1, 8 and 15, every 4 weeks. RESULTS: Out of the 42 patients enrolled, 41 were evaluable for their response, and all 42 for their toxicity. The patient's characteristics were as follows; median age=60 years (42~73), median PS=1 (range 0~2), a gender ratio 31: 11 males/females, with stages IIIA, IIIB and IV in 3, 14 and 25 cases. The objective responses included a partial response (PR) 8/41 (19.5%), a stable disease 15/41 (36.6%) and a progressive disease 18/41 (43.9%). The median time-to progression (TTP) and survival were 4 months, ranging from 2 to 14 months, and 8 months, ranging from 2 to 17+ months, respectively. Grade 3 neutropenia was seen in 19% of the patient, and there was no grade 4 neutropenia or episodes of febrile neutropenia. No grade 4 thrombocytopenia or other grade 3/4 non-hematological toxicities were observed. CONCLUSION: The combination of gemcitabine/vinorelbine is active and well tolerated in patients with advanced NSCLC having failed prior taxane/platinum therapy. FAU - Kim, Yoon Jae AU - Kim YJ FAU - Sohn, Joo Hyuk AU - Sohn JH FAU - Kim, Chul AU - Kim C FAU - Kim, Yong Tai AU - Kim YT FAU - Kim, Hai Jin AU - Kim HJ FAU - Ahn, Joong Bae AU - Ahn JB FAU - Kim, Se Kyu AU - Kim SK FAU - Chang, Joon AU - Chang J FAU - Yoo, Nae Choon AU - Yoo NC FAU - Kim, Joo Hang AU - Kim JH FAU - Cho, Jae Yong AU - Cho JY LA - eng PT - Journal Article PL - Korea (South) TA - Cancer Res Treat JT - Cancer research and treatment JID - 101155137 OTO - NOTNLM OT - Gemcitabine OT - Non-small cell lung cancer OT - Second line chemotherapy OT - Vinorelbine EDAT- 2003/08/01 00:00 MHDA- 2003/08/01 00:01 CRDT- 2015/12/19 06:00 PHST- 2015/12/19 06:00 [entrez] PHST- 2003/08/01 00:00 [pubmed] PHST- 2003/08/01 00:01 [medline] AID - 10.4143/crt.2003.35.4.294 [doi] PST - ppublish SO - Cancer Res Treat. 2003 Aug;35(4):294-8. doi: 10.4143/crt.2003.35.4.294.