A randomized phase II study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non‐small cell lung cancer harboring EGFR mutations (JMTO LC12‐01)
Abstract Background Gefitinib (G) is a recommended molecular‐targeted agent for elderly patients with epidermal growth factor receptor (EGFR)‐mutant non‐small cell lung cancer (NSCLC). Docetaxel (Doc) and pemetrexed (Pem) have similar efficacies, and either is often used as the sole agent during tre...
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| Format: | Article |
| Language: | English |
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Wiley
2022-06-01
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| Series: | Thoracic Cancer |
| Subjects: | |
| Online Access: | https://doi.org/10.1111/1759-7714.14465 |
| _version_ | 1818465649656070144 |
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| author | Kazuhiro Asami Masahiko Ando Takashi Nishimura Takashi Yokoi Atsuhisa Tamura Koichi Minato Masahide Mori Fumitaka Ogushi Akiyoshi Yamamoto Hiroshige Yoshioka Masaaki Kawahara Shinji Atagi |
| author_facet | Kazuhiro Asami Masahiko Ando Takashi Nishimura Takashi Yokoi Atsuhisa Tamura Koichi Minato Masahide Mori Fumitaka Ogushi Akiyoshi Yamamoto Hiroshige Yoshioka Masaaki Kawahara Shinji Atagi |
| author_sort | Kazuhiro Asami |
| collection | DOAJ |
| description | Abstract Background Gefitinib (G) is a recommended molecular‐targeted agent for elderly patients with epidermal growth factor receptor (EGFR)‐mutant non‐small cell lung cancer (NSCLC). Docetaxel (Doc) and pemetrexed (Pem) have similar efficacies, and either is often used as the sole agent during treatment. The efficacy of continuing G after progressive disease (PD) develops has been reported. It remains unclear whether the continuation of G in combination with a single cytotoxic agent beyond PD is beneficial for elderly patients. Here, we conducted a randomized phase II study to assess the efficacy and safety of cytotoxic chemotherapy with G for elderly patients with progressive EGFR‐mutant NSCLC. Methods Elderly patients with EGFR‐mutant NSCLC with PD previously treated with G were enrolled. Patients received Pem 500 mg/m or Doc 60 mg/m every 21 days and were randomly assigned to receive chemotherapy with 250 mg G (G+ Doc/Pem arm) or without G (Doc/Pem arm) until further disease progression or unacceptable toxicity. Results This trial was terminated early owing to slow accrual. A group of 22 patients underwent analysis. The primary endpoint, progression‐free survival (PFS), was significantly longer in the G + Doc/Pem arm (median: 1.6 months vs. 5.6 months, hazard ratio = 0.40, 95% CI: 0.16–0.99, p = 0.0391). Adverse events ≥ grade 3 were more frequent in the G + Doc/Pem arm (45.5% vs. 90.9%, p = 0.032). Conclusions Patients on G and Pem or Doc beyond PD showed a longer PFS than those on single‐agent chemotherapy; however, it was associated with increased toxicity. |
| first_indexed | 2024-04-13T20:48:27Z |
| format | Article |
| id | doaj.art-da6e29d4b8354daa90ef3bf9476a014a |
| institution | Directory Open Access Journal |
| issn | 1759-7706 1759-7714 |
| language | English |
| last_indexed | 2024-04-13T20:48:27Z |
| publishDate | 2022-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | Thoracic Cancer |
| spelling | doaj.art-da6e29d4b8354daa90ef3bf9476a014a2022-12-22T02:30:36ZengWileyThoracic Cancer1759-77061759-77142022-06-0113121827183610.1111/1759-7714.14465A randomized phase II study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non‐small cell lung cancer harboring EGFR mutations (JMTO LC12‐01)Kazuhiro Asami0Masahiko Ando1Takashi Nishimura2Takashi Yokoi3Atsuhisa Tamura4Koichi Minato5Masahide Mori6Fumitaka Ogushi7Akiyoshi Yamamoto8Hiroshige Yoshioka9Masaaki Kawahara10Shinji Atagi11Asami Naika Clinic Tokyo JapanDepartment of Advanced Medicine Nagoya University Hospital Nagoya JapanDepartment of Respiratory Medicine Kyoto Katsura Hospital Kyoto JapanDepartment of Thoracic Oncology Hyogo College of Medicine Hyogo JapanDepartment of Center for Pulmonary Diseases Tokyo National Hospital Tokyo JapanDepartment of Respiratory Medicine Gunma Prefectural Cancer Center Gunma JapanDepartment of Thoracic Oncology National Hospital Organization Osaka Toneyama Medical Center Osaka JapanDepartment of Respiratory Medicine Kochi National Hospital Kochi JapanDepartment of Respiratory Medicine Takamatsu Red Cross Hospital Kagawa JapanDepartment of Thoracic Oncology Kansai Medical University Hospital Osaka JapanDepartment of Respiratory Medicine KKR Otemae Hospital Osaka JapanDepartment of Thoracic Oncology National Hospital Organization Kinki‐Chuo Chest Medical Center Osaka JapanAbstract Background Gefitinib (G) is a recommended molecular‐targeted agent for elderly patients with epidermal growth factor receptor (EGFR)‐mutant non‐small cell lung cancer (NSCLC). Docetaxel (Doc) and pemetrexed (Pem) have similar efficacies, and either is often used as the sole agent during treatment. The efficacy of continuing G after progressive disease (PD) develops has been reported. It remains unclear whether the continuation of G in combination with a single cytotoxic agent beyond PD is beneficial for elderly patients. Here, we conducted a randomized phase II study to assess the efficacy and safety of cytotoxic chemotherapy with G for elderly patients with progressive EGFR‐mutant NSCLC. Methods Elderly patients with EGFR‐mutant NSCLC with PD previously treated with G were enrolled. Patients received Pem 500 mg/m or Doc 60 mg/m every 21 days and were randomly assigned to receive chemotherapy with 250 mg G (G+ Doc/Pem arm) or without G (Doc/Pem arm) until further disease progression or unacceptable toxicity. Results This trial was terminated early owing to slow accrual. A group of 22 patients underwent analysis. The primary endpoint, progression‐free survival (PFS), was significantly longer in the G + Doc/Pem arm (median: 1.6 months vs. 5.6 months, hazard ratio = 0.40, 95% CI: 0.16–0.99, p = 0.0391). Adverse events ≥ grade 3 were more frequent in the G + Doc/Pem arm (45.5% vs. 90.9%, p = 0.032). Conclusions Patients on G and Pem or Doc beyond PD showed a longer PFS than those on single‐agent chemotherapy; however, it was associated with increased toxicity.https://doi.org/10.1111/1759-7714.14465chemotherapyelderlyepidermal growth factor receptor mutationgefitinibnon‐small cell lung cancer |
| spellingShingle | Kazuhiro Asami Masahiko Ando Takashi Nishimura Takashi Yokoi Atsuhisa Tamura Koichi Minato Masahide Mori Fumitaka Ogushi Akiyoshi Yamamoto Hiroshige Yoshioka Masaaki Kawahara Shinji Atagi A randomized phase II study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non‐small cell lung cancer harboring EGFR mutations (JMTO LC12‐01) Thoracic Cancer chemotherapy elderly epidermal growth factor receptor mutation gefitinib non‐small cell lung cancer |
| title | A randomized phase II study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non‐small cell lung cancer harboring EGFR mutations (JMTO LC12‐01) |
| title_full | A randomized phase II study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non‐small cell lung cancer harboring EGFR mutations (JMTO LC12‐01) |
| title_fullStr | A randomized phase II study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non‐small cell lung cancer harboring EGFR mutations (JMTO LC12‐01) |
| title_full_unstemmed | A randomized phase II study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non‐small cell lung cancer harboring EGFR mutations (JMTO LC12‐01) |
| title_short | A randomized phase II study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non‐small cell lung cancer harboring EGFR mutations (JMTO LC12‐01) |
| title_sort | randomized phase ii study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non small cell lung cancer harboring egfr mutations jmto lc12 01 |
| topic | chemotherapy elderly epidermal growth factor receptor mutation gefitinib non‐small cell lung cancer |
| url | https://doi.org/10.1111/1759-7714.14465 |
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