Combination Chemotherapy with Paclitaxel and Gemcitabine Followed by Concurrent Chemoradiotherapy in Non-operable Localized Non-small Cell Lung Cancer. A Hellenic Cooperative Oncology Group (HeCOG) Phase II Study

• Published in: Anticancer research 2007-11, Vol.27 (6C), p.4391-4395
• Main Authors: KOSMIDIS, P, FOUNTZILAS, G, PANTELAKOS, P, ATHANASIOU, H, MISAILIDOU, D, TSEKERIS, P, PAVLIDIS, N, BAKA, S, SAMANTAS, E, DIMOPOULOS, A. M, GOGAS, H, SKARLOS, D, PAPACOSTAS, P, BOUKOVINAS, J, BAKOGIANNIS, Ch
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - mortality; Carcinoma, Non-Small-Cell Lung - radiotherapy; Combined Modality Therapy; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Female; Humans; Kaplan-Meier Estimate; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Lung Neoplasms - radiotherapy; Male; Medical sciences; Middle Aged; Paclitaxel - administration & dosage; Pneumology; Radiotherapy; Tumors; Tumors of the respiratory system and mediastinum
• ISSN: 0250-7005; 1791-7530

Concurrent chemoradiotherapy has become a standard therapy for locoregionally advanced inoperable non-small cell lung cancer (NSCLC). The purpose of this phase II trial was to evaluate the efficacy and toxicity of concurrent chemoradiotherapy following induction with non-platinum chemotherapy in patients with inoperable locally advanced NSCLC. Patients and Methods: All patients with locally advanced inoperable NSCLC ECOG performance status (PS): 0-1 following staging received paclitaxel 200 mg/m 2 in a 3-h infusion on day 1 and gemcitabine 1000 mg/m 2 on days 1 and 8 every 21 days for two cycles. The patients with a response or stable disease (SD) continued to receive paclitaxel 60 mg/m 2 weekly and radiotherapy 63 Gy given at 1.8 Gy once a day for 7 weeks. Results: Forty-three eligible patients entered the study. The median age was 63 years (range 42-76), male 93%, IIIB 63% and IIIA 37%. Following induction 15 (36.5%) of the patients responded: complete response (CR), 2%; partial response (PR), 33%; and 19 (46.5%) SD. From those with SD, 7 (37%) improved to a PR following concurrent chemoradiotherapy. With a median follow-up of 44 months (95% CI: range 36-53) the median survival was 20.8 months (95% CI: range 15.4-26.3) and time-to-progression 8.4 months (95% CI: range 6.2-10.6). The median survival of those who had improved response from SD to PR was 31.4 months (95% CI: range 18.7-44.1) versus 20.8 months (95% CI: range 5.5-11.3) for those who had no improvement (p=0.20). The commonest grade 3/4 toxicity in induction was neutropenia 12% with 2 febrile neutropenic patients whereas in the concurrent chemoradiotherapy neutropenia, neurotoxicity and oesophagitis were observed in 6% of the patients. Conclusion: Concurrent chemoradiotherapy following induction chemotherapy in patients with stage III NSCLC is feasible with reasonable efficacy and acceptable toxicity.