Moderately Hypofractionated Once-Daily Compared With Twice-Daily Thoracic Radiation Therapy Concurrently With Etoposide and Cisplatin in Limited-Stage Small Cell Lung Cancer : A Multicenter, Phase II, Randomized Trial
Copyright © 2021. Published by Elsevier Inc..
PURPOSE: Chemotherapy and concurrent thoracic radiation therapy (CCTRT) followed by prophylactic cranial irradiation (PCI) is the standard of care for limited-stage small cell lung cancer (LS-SCLC). We aimed to compare the efficacy and toxicity of moderately hypofractionated once-daily CCTRT with that of a standard twice-daily regimen.
METHODS AND MATERIALS: This multicenter, phase 2, randomized study enrolled patients aged 18 to 75 years old who had pathologically confirmed LS-SCLC and an Eastern Cooperative Oncology Group performance status of 0 to 1. Eligible patients received 4 to 6 cycles of etoposide-cisplatin chemotherapy and were randomized to receive twice-daily CCTRT at 45 Gray (Gy) in 30 fractions or once-daily CCTRT at 65 Gy in 26 fractions, commencing with cycles 1 to 3 of chemotherapy. PCI was given to good responders. The primary endpoint was progression-free survival (PFS).
RESULTS: The analyses included 182 patients, with 94 in the twice-daily group and 88 in the once-daily group. CCTRT started with cycle 3 of chemotherapy for most patients (80.2%). At a median follow-up of 24.3 months, the median PFS was 13.4 months (95% confidence interval [CI], 10.8-16.0) in the twice-daily group versus 17.2 months (95% CI, 11.8-22.6) in the once-daily group (P = .031), with 2-year PFS rates of 28.4% (95% CI, 18.2-38.6) and 42.3% (95% CI, 31.1-53.5), respectively. The estimated overall survival was 33.6 months in the twice-daily group versus 39.3 months in the once-daily group (P = .137). The median locoregional PFS was 23.9 months in the twice-daily group and was not reached in the once-daily group (P = .017). The incidences of most toxicities were similar in both groups, except for a higher incidence of ≥grade 3 acute lymphopenia in the once-daily group (71.7% vs 40.2% in the twice-daily group; P < .001). There was no difference in the incidences of ≥grade 3 esophagitis (17.4% vs 15.3%, respectively), pneumonitis (3.3% vs 2.4%, respectively) or treatment-related death (2.2% vs 1.2%, respectively) between the once-daily and twice-daily groups.
CONCLUSIONS: Moderately hypofractionated, once-daily CCTRT showed improved PFS and similar toxicities compared with twice-daily CCTRT in LS-SCLC. This regimen should be evaluated for comparison in a phase 3 randomized trial.
| Errataetall: |
CommentIn: Int J Radiat Oncol Biol Phys. 2022 Apr 1;112(5):1067-1070. - PMID 35286875 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:111 |
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| Enthalten in: |
International journal of radiation oncology, biology, physics - 111(2021), 2 vom: 01. Okt., Seite 424-435 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Qiu, Bo [VerfasserIn] |
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| Links: |
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| Themen: |
6PLQ3CP4P3 |
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| Anmerkungen: |
Date Completed 29.09.2021 Date Revised 22.04.2022 published: Print-Electronic ClinicalTrials.gov: NCT02337712 CommentIn: Int J Radiat Oncol Biol Phys. 2022 Apr 1;112(5):1067-1070. - PMID 35286875 Citation Status MEDLINE |
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| doi: |
10.1016/j.ijrobp.2021.05.003 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM325440182 |
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| 245 | 1 | 0 | |a Moderately Hypofractionated Once-Daily Compared With Twice-Daily Thoracic Radiation Therapy Concurrently With Etoposide and Cisplatin in Limited-Stage Small Cell Lung Cancer |b A Multicenter, Phase II, Randomized Trial |
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| 500 | |a Date Revised 22.04.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02337712 | ||
| 500 | |a CommentIn: Int J Radiat Oncol Biol Phys. 2022 Apr 1;112(5):1067-1070. - PMID 35286875 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021. Published by Elsevier Inc. | ||
| 520 | |a PURPOSE: Chemotherapy and concurrent thoracic radiation therapy (CCTRT) followed by prophylactic cranial irradiation (PCI) is the standard of care for limited-stage small cell lung cancer (LS-SCLC). We aimed to compare the efficacy and toxicity of moderately hypofractionated once-daily CCTRT with that of a standard twice-daily regimen | ||
| 520 | |a METHODS AND MATERIALS: This multicenter, phase 2, randomized study enrolled patients aged 18 to 75 years old who had pathologically confirmed LS-SCLC and an Eastern Cooperative Oncology Group performance status of 0 to 1. Eligible patients received 4 to 6 cycles of etoposide-cisplatin chemotherapy and were randomized to receive twice-daily CCTRT at 45 Gray (Gy) in 30 fractions or once-daily CCTRT at 65 Gy in 26 fractions, commencing with cycles 1 to 3 of chemotherapy. PCI was given to good responders. The primary endpoint was progression-free survival (PFS) | ||
| 520 | |a RESULTS: The analyses included 182 patients, with 94 in the twice-daily group and 88 in the once-daily group. CCTRT started with cycle 3 of chemotherapy for most patients (80.2%). At a median follow-up of 24.3 months, the median PFS was 13.4 months (95% confidence interval [CI], 10.8-16.0) in the twice-daily group versus 17.2 months (95% CI, 11.8-22.6) in the once-daily group (P = .031), with 2-year PFS rates of 28.4% (95% CI, 18.2-38.6) and 42.3% (95% CI, 31.1-53.5), respectively. The estimated overall survival was 33.6 months in the twice-daily group versus 39.3 months in the once-daily group (P = .137). The median locoregional PFS was 23.9 months in the twice-daily group and was not reached in the once-daily group (P = .017). The incidences of most toxicities were similar in both groups, except for a higher incidence of ≥grade 3 acute lymphopenia in the once-daily group (71.7% vs 40.2% in the twice-daily group; P < .001). There was no difference in the incidences of ≥grade 3 esophagitis (17.4% vs 15.3%, respectively), pneumonitis (3.3% vs 2.4%, respectively) or treatment-related death (2.2% vs 1.2%, respectively) between the once-daily and twice-daily groups | ||
| 520 | |a CONCLUSIONS: Moderately hypofractionated, once-daily CCTRT showed improved PFS and similar toxicities compared with twice-daily CCTRT in LS-SCLC. This regimen should be evaluated for comparison in a phase 3 randomized trial | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
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| 700 | 1 | |a Pang, QingSong |e verfasserin |4 aut | |
| 700 | 1 | |a Zhu, ZhengFei |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Xi |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Bin |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Li |e verfasserin |4 aut | |
| 700 | 1 | |a Fang, JianLan |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, MaoSheng |e verfasserin |4 aut | |
| 700 | 1 | |a Jiang, XiaoBo |e verfasserin |4 aut | |
| 700 | 1 | |a Guo, SuPing |e verfasserin |4 aut | |
| 700 | 1 | |a Guo, JinYu |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, DaQuan |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, FangJie |e verfasserin |4 aut | |
| 700 | 1 | |a Chu, Chu |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, XiaoYan |e verfasserin |4 aut | |
| 700 | 1 | |a Xie, ChuanMiao |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Hui |e verfasserin |4 aut | |
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