Eisaku Miyauchi1, Akira Inoue2, Kunihiko Kobayashi3, Makoto Maemondo4, Shunichi Sugawara5, Satoshi Oizumi6, Hiroshi Isobe7, Akihiko Gemma8, Yasuo Saijo9, Hirohisa Yoshizawa10, Koichi Hagiwara11, Toshihiro Nukiwa12. 1. Department of Respiratory Medicine, Tohoku University Hospital, Sendai. 2. Department of Respiratory Medicine, Tohoku University Hospital, Sendai akinoue@idac.tohoku.ac.jp. 3. Department of Respiratory Medicine, Saitama Medical University Internal Medical Center, Saitama. 4. Department of Respiratory Medicine, Miyagi Cancer Center, Miyagi. 5. Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai. 6. First Department of Medicine, Hokkaido University School of Medicine, Sapporo. 7. Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo. 8. Department of Pulmonary Medicine and Oncology, Graduate School, Nippon Medical School, Tokyo. 9. Department of Medical Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata. 10. Bioscience Medical Research Center, Niigata University Medical & Dental Hospital, Niigata. 11. Department of Respiratory Medicine, Saitama Medical University, Saitama. 12. Department of Respiratory Medicine, South Miyagi Medical Center, Miyagi, Japan.
Abstract
OBJECTIVE: Epidermal growth factor receptor tyrosine kinase inhibitors are effective as first-line therapy for advanced non-small cell lung cancer patients harboring epidermal growth factor receptor mutations. However, it is unknown whether second-line platinum-based chemotherapy after epidermal growth factor receptor tyrosine kinase inhibitor therapy could lead to better outcomes. We evaluated the efficacy of second-line platinum-based chemotherapy after gefitinib for advanced non-small cell lung cancers harboring epidermal growth factor receptor mutations (the NEJ002 study). METHODS:Seventy-one non-small cell lung cancers, treated with gefitinib as first-line therapy and then receivingplatinum-based chemotherapy as second-line therapy were evaluated in NEJ002. Patients were evaluated for antitumor response to second-line chemotherapy by computed tomography according to the criteria of the Response Evaluation Criteria in Solid Tumors group (version 1.0). RESULTS: Of the 71 patients receivingplatinum-based chemotherapy after first-line gefitinib, a partial response was documented in 25.4% (18/71), stable disease in 43.7% (31/71) and progression of disease in 21.1% (15/71). The objective response and disease control rates were 25.4% (18/71) and 69% (49/71), respectively. There was no significant difference between first- and second-line chemotherapy in objective response and disease control rates for advanced non-small cell lung cancer harboring activating epidermal growth factor receptor mutations. In the analysis of epidermal growth factor receptor mutation types, the objective responses of deletions in exon 19 and a point mutation in exon 21 (L858R) were 27.3% (9/33) and 28.1% (9/32), respectively, but these differences between objective response rates were not significant. CONCLUSIONS: The efficacy of second-line platinum-based chemotherapy followed at progression by gefitinib was similar to first-line platinum-based chemotherapy, and epidermal growth factor receptor mutation types did not influence the efficacy of second-line platinum-based chemotherapy.
RCT Entities:
OBJECTIVE:Epidermal growth factor receptor tyrosine kinase inhibitors are effective as first-line therapy for advanced non-small cell lung cancerpatients harboring epidermal growth factor receptor mutations. However, it is unknown whether second-line platinum-based chemotherapy after epidermal growth factor receptor tyrosine kinase inhibitor therapy could lead to better outcomes. We evaluated the efficacy of second-line platinum-based chemotherapy after gefitinib for advanced non-small cell lung cancers harboring epidermal growth factor receptor mutations (the NEJ002 study). METHODS: Seventy-one non-small cell lung cancers, treated with gefitinib as first-line therapy and then receiving platinum-based chemotherapy as second-line therapy were evaluated in NEJ002. Patients were evaluated for antitumor response to second-line chemotherapy by computed tomography according to the criteria of the Response Evaluation Criteria in Solid Tumors group (version 1.0). RESULTS: Of the 71 patients receiving platinum-based chemotherapy after first-line gefitinib, a partial response was documented in 25.4% (18/71), stable disease in 43.7% (31/71) and progression of disease in 21.1% (15/71). The objective response and disease control rates were 25.4% (18/71) and 69% (49/71), respectively. There was no significant difference between first- and second-line chemotherapy in objective response and disease control rates for advanced non-small cell lung cancer harboring activating epidermal growth factor receptor mutations. In the analysis of epidermal growth factor receptor mutation types, the objective responses of deletions in exon 19 and a point mutation in exon 21 (L858R) were 27.3% (9/33) and 28.1% (9/32), respectively, but these differences between objective response rates were not significant. CONCLUSIONS: The efficacy of second-line platinum-based chemotherapy followed at progression by gefitinib was similar to first-line platinum-based chemotherapy, and epidermal growth factor receptor mutation types did not influence the efficacy of second-line platinum-based chemotherapy.
Authors: J Remon; D Isla; P Garrido; J de Castro; M Majem; N Viñolas; A Artal; E Carcereny; M R García-Campelo; P Lianes; M Provencio; O Juan; P Diz; R Blanco; R Lopez-Castro; I Maestu; C Vadell; E Felip Journal: Clin Transl Oncol Date: 2017-06-28 Impact factor: 3.405