| General information |
| Database: | DB00785 |
| Objective: | The aim of our study was to investigate the efficacy and safety of pemetrexed monotherapy in chemona ve Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients with epidermal growth factor receptor (EGFR) wildtype or unknown advanced nonsquamous non small cell lung cancer (non small cell lung cancer). |
| Authors: | Hata A, et al |
| Title: | a phase II study of pemetrexed monotherapy in chemona ve Eastern Cooperative Oncology Group performance status 2 patients with EGFR wildtype or unknown advanced nonsquamous non small cell lung cancer (HANSHIN Oncology Group 002). |
| Journal: | Cancer Chemother Pharmacol. |
| Year: | 2015 |
| PMID: | 25925001 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | pemetrexed
|
| Target: | Thymidylate synthase
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced nonsquamous non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II study |
| Key Patients Feature: | patients with EGFR wildtype or unknown advanced nonsquamous non small cell lung cancer |
| Biomarker: | EGFR wildtype or unknown |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Pemetrexed was administered at 500 mg/m(2) triweekly until progression with supplementations in chemona ve ECOG PS 2 patients with EGFR wildtype or unknown advanced nonsquamous non small cell lung cancer. |
| Primary End Point: | progression free survival (PFS) |
| Secondary End Point: | response rate (RR), disease control rate (DCR), overall survival, and toxicities. |
| Patients Number: | 28 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 11.50% |
| Disease Control Rate: | 53.80% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.0 [95 % confidence interval (CI) 1.95.7] months |
| Median OS A vs. C: | 9.5 (95 % CI 3.312.5) months |
| Adverse Event(agent arm): | Adverse events (AEs) were assessed for 28 patients who had undergone the protocol treatment (Table 2). Common (more than and equal to 10 %) grade 3/4 toxicities included 7 (27 %) neutropenia, 7 (27 %) leukopenia, 4 (15 %) fatigue, and 3 (12 %) thrombocytopenia. Febrile neutropenia and interstitial lung disease were not observed. There were no treatmentrelated deaths (TRDs). |
| Conclusions: | advanced nonsquamous non small cell lung cancer |