PMID- 30362335 OWN - NLM STAT- MEDLINE DCOM- 20190205 LR - 20200225 IS - 2476-762X (Electronic) IS - 1513-7368 (Print) IS - 1513-7368 (Linking) VI - 19 IP - 10 DP - 2018 Oct 26 TI - A Phase IV Efficacy Study of Formeta Plus Carboplatin as First-Line Treatment of Advanced Non-Squamous, Non-Small Cell Lung Cancer in Iran: An Affordable Price with Clinical Benefit. PG - 2973-2978 AB - Background: This study performed to assess the efficacy and safety of Formeta (generic form of Pemetrexed) plus Carboplatin as first-line chemotherapy in advanced stage, non- squamous, non small cell lung cancer ( NSCLC) in Iran. Methods: This was a post marketing single-arm phase IV efficacy study of Formeta (manufactured by Oncomed.,Czech Republic ) and Carboplatin in chemo-naive advanced non-squamous NSCLC Iranian patients. Patients received up to six cycles of Formeta (500 mg/m2) combined with Carboplatin (area under the curve: AUC 5) every 3 weeks. The primary endpoint was the progression free survival (PFS) and secondary endpoints were safety and overall survival (OS). Results: Fifty-two patients were enrolled between June 2014 to January 2016, and 44 patients were evaluable for both safety and efficacy. Partial and complete responses were achieved in 19 (36.5 %) and 2 (3.8%) patients, respectively as well as stable disease in 8 patients (15.3 %). Median of PFS and OS were 7.9 +/- 1.1 months and 12.43+/-0.6 months, respectively. Anemia was the most prevalent adverse events of this regimen. Grades 3 or 4 of adverse events were not observed in any patients. Non-hematologic and other grades of hematologic toxicities were generally mild, and there were no treatment-related deaths. Conclusion: The combination of Formeta and Carboplatin was effective in advanced non-squamous NSCLC and can be a suitable candidate as first-line treatment in these patient's population. CI - Creative Commons Attribution License FAU - Khosravi, Adnan AU - Khosravi A AD - Tobacco Prevention and Control Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran. Email: sh_seifi@sbmu.ac.ir FAU - Salimi, Babak AU - Salimi B FAU - Esfahani-Monfared, Zahra AU - Esfahani-Monfared Z FAU - Seifi, Sharareh AU - Seifi S FAU - Mirtavoos-Mahyari, Hanifeh AU - Mirtavoos-Mahyari H LA - eng PT - Clinical Trial, Phase IV PT - Journal Article DEP - 20181026 PL - Thailand TA - Asian Pac J Cancer Prev JT - Asian Pacific journal of cancer prevention : APJCP JID - 101130625 RN - 04Q9AIZ7NO (Pemetrexed) RN - BG3F62OND5 (Carboplatin) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Carboplatin/*therapeutic use MH - Carcinoma, Non-Small-Cell Lung/*drug therapy MH - Disease-Free Survival MH - Female MH - Humans MH - Iran MH - Lung Neoplasms/*drug therapy MH - Male MH - Middle Aged MH - Pemetrexed/*therapeutic use PMC - PMC6291026 OTO - NOTNLM OT - *Non small cell lung cancer OT - *carboplatin OT - *pemetrexed OT - *chemotherapy OT - *safety EDAT- 2018/10/27 06:00 MHDA- 2019/02/06 06:00 PMCR- 2018/03/01 CRDT- 2018/10/27 06:00 PHST- 2018/10/27 06:00 [entrez] PHST- 2018/10/27 06:00 [pubmed] PHST- 2019/02/06 06:00 [medline] PHST- 2018/03/01 00:00 [pmc-release] AID - APJCP-19-2973 [pii] AID - 10.22034/APJCP.2018.19.10.2973 [doi] PST - epublish SO - Asian Pac J Cancer Prev. 2018 Oct 26;19(10):2973-2978. doi: 10.22034/APJCP.2018.19.10.2973.