S-1–Based Chemoradiotherapy Followed by Consolidation Chemotherapy With S-1 in Elderly Patients With Esophageal Squamous Cell Carcinoma: A Multicenter Phase II Trial

Wang, Xin; Ge, Xiaolin; Wang, Xiaomin; Zhang, Wencheng; Zhou, Huaiyu; Lin, Yu; Qie, Shuo; Hu, Miaomiao; Wang, Wei; Liu, Ke; Pang, Qingsong; Li, Minghe; Chen, Junqiang; Liu, Miaoling; Zhang, Kaixian; Li, Ling; Shi, Yonggang; Deng, Wei; Li, Chen; Ni, Wenjie; Chang, Xiao; Han, Won Ho; Deng, Lei; Wang, Wenqing; Liang, Jun; Bi, Nan; Zhang, Tao; Liu, Wenyang; Wang, Jianyang; Zhai, Yirui; Feng, Qinfu; Chen, Dongfu; Zhou, Zongmei; Zhao, Yidian; Sun, Xinchen; Xiao, Zefen

doi:10.3389/fonc.2020.01499

Cited by 11 publications

(25 citation statements)

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“…reported that the rate of grade ≥3 toxicities was 50% among 50 elderly EC patients who received definitive radiotherapy ( 23 ). Furthermore, two similar recent studies exploring the efficacy and safety of S-1 based concurrent chemoradiotherapy in elderly EC patients reported high incidence of side effects with 28% of grade 3−4 acute toxicities and 55.4% of grade 3−4 leucocytopenia, respectively ( 24 , 25 ). Zhang et al .…”

Section: Discussionmentioning

confidence: 92%

“…Recently, two studies published the efficacy of S-1 based chemoradiotherapy in elderly patients with ESCC. The MST were 22.6 and 18.2 months, respectively ( 24 , 25 ). The aformentioned survival data demonstrated that radiotherapy combined with nimotuzumab achieved acceptable therapeutic effects and more importantly with lower toxicities.…”

Section: Discussionmentioning

confidence: 98%

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Radiotherapy combined with nimotuzumab for elderly esophageal cancer patients: A phase II clinical trial

Yang¹,

Zhai²,

Bi³

et al. 2021

Chinese Journal of Cancer Research

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Objective To investigate the safety and efficacy of nimotuzumab combined with radiotherapy for elderly patients with non-resectable esophageal carcinoma (EC). Methods Eligible patients were aged 70 years or older and had treatment-naïve, histologically proven inoperable locally advanced EC. Enrolled patients received radiotherapy with a total dose of 50−60 Gy in 25−30 fractions, concurrent with weekly infusion of nimotuzumab. The primary end point was the rate of more than grade 3 toxicities. Results From June 2011 to July 2016, 46 patients with stage II−IV EC with a median age of 76.5 years were enrolled. There were 10, 28 and 8 patients with stage II, III and IV disease, respectively. The common acute toxicities included esophagitis (grade 1−2, 75.4%; grade 3, 8.7%), pneumonitis (grade 1, 4.3%; grade 2, 6.5%; grade 3, 2.2%), leukopenia (grade 1−2, 60.9%; grade 3−4, 4.4%), gastrointestinal reaction (grade 1−2, 17.3%; grade 3, 2.2%), thrombocytopenia (grade 1−2, 21.7%; grade 3, 2.2%), and radiothermitis (grade 1−2, 39.2%). The incidence of grade 3−4 adverse effects was 17.4%. No grade 5 toxicities were observed. Clinical complete response, partial response, stable disease, and progressive disease were observed in 1 (2.2%), 31 (67.4%), 12 (26.1%), and 2 (4.3%) patients, respectively. The median overall survival (OS) and progression-free survival (PFS) were 17 and 10 months, respectively. The 2-, 3-, and 5-year OS and PFS rates were 30.4%, 21.7%, 19.6%, and 26.1%, 19.6%, 19.6%, respectively. Conclusions Nimotuzumab combined with radiotherapy is a safe and effective therapy for elderly patients who are not surgical candidates. Further studies are warranted to confirm its therapeutic effects in elderly EC patients.

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Section: Discussionmentioning

confidence: 92%

Section: Discussionmentioning

confidence: 98%

Radiotherapy combined with nimotuzumab for elderly esophageal cancer patients: A phase II clinical trial

Yang¹,

Zhai²,

Bi³

et al. 2021

Chinese Journal of Cancer Research

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“…RT alone should be recommended with caution even in the eldest group (aged > 85 years). If patients cannot tolerate doublet CT combined with RT, single-drug oral CT drugs can be considered, such as S1, Xeloda, and other uorouracil analogues [12,35].…”

Section: Discussionmentioning

confidence: 99%

“…Thus, treatment for elderly patients with esophageal carcinoma appears to be underutilized [9]. Controversies on the selection of the optimal treatment strategy for elderly patients with curable EC, including esophagectomy versus CRT [10,11] or CRT versus radiotherapy (RT) alone, still exist [8,12]. For instance, Abrams JA et al have reported that esophagectomy may be associated with better survival for early-stage EC patients aged ≥ 65 years compared to CRT [11], whereas Koeter M et al have found that survival was comparable among elderly patients (aged ≥ 75 years) with esophageal squamous cell carcinoma (ESCC) who underwent surgery or received de nitive CRT.…”

Section: Introductionmentioning

confidence: 99%

“…For instance, Abrams JA et al have reported that esophagectomy may be associated with better survival for early-stage EC patients aged ≥ 65 years compared to CRT [11], whereas Koeter M et al have found that survival was comparable among elderly patients (aged ≥ 75 years) with esophageal squamous cell carcinoma (ESCC) who underwent surgery or received de nitive CRT. [10] However, most previous studies have included a small number of samples or only compared the e ciency of two main treatment patterns [10,11], with inconsistent de nitions of "elderly population" from aged 65 years and older [11,13] to ≥ 70 [12,14] or 75 years [10] or more than 80 years [15]. Given the con icting and insu cient data on this patient population, the optimal treatment strategy for elderly patients with potentially curable EC needs to be further investigated.…”

Section: Introductionmentioning

confidence: 99%

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Treatment patterns and Outcomes of Elderly Patients with Potentially Curable Esophageal Cancer

Yang

Xie

et al. 2021

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Background: The proportion of elderly patients with esophageal cancer (EC) is increasing due to prolonged life expectancy and aging process. However, the optimal treatment strategy for elderly patients (aged ≥70 years) with EC remains controversial.Methods: Eligible patients with cT1b-4aNxM0 EC were identified in the Surveillance, Epidemiology, and End Results database from 2010 to 2016. Treatment patterns were divided into five groups: surgical resection (S), chemoradiotherapy (CRT), radiotherapy (RT), chemotherapy (CT), or observation with no treatment (Obs). Survival between groups was compared using the log-rank test, and the Cox proportional hazards model was used to identify factors associated with overall survival (OS).Results: A total of 3233 patients with potentially curable EC were identified. Of all the patients included, 29.1%, 48.2%, 8.7%, and 3.5% received S, CRT, RT, and CT, respectively, whereas 10.5% underwent Obs. The 3-year OS estimates were 45.8% (95% confidence interval [CI]: 42.2–49.8%), 26.1% (95% CI: 23.5–28.9%), 12.2% (95% CI: 8.4–17.8%), 14.9% (95% CI: 8.4–26.4%), and 6.7% (95% CI: 4.0–11.0%) for S, CRT, RT, CT, and Obs (p<0.001), respectively. However, the survival benefits of surgery over CRT gradually weakened with the increase in age, and the survival benefit of surgery was statistically non-significant for EC patients aged ≥80 years (p=0.41). Multivariate analysis showed that treatment patterns, age, tumor grade, T stage, N stage, and marital status were significantly associated with OS.Conclusion: Generally, the use of surgery was associated with the longest OS, and CRT was superior to RT or CT alone in elderly patients with curable EC. For patients intolerable to surgery or aged ≥80 years, definitive CRT should be considered as a preferable option. The optimal treatment strategy for elderly patients with EC should consider comprehensive geriatric assessment, survival benefit, and patient preference in a multidisciplinary setting.

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Effectiveness of S-1–Based Chemoradiotherapy in Patients 70 Years and Older With Esophageal Squamous Cell Carcinoma

Wang,

Han,

Zhang

et al. 2023

JAMA Netw Open

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ImportanceDouble-agent intravenous chemotherapy concurrent with radiotherapy is the standard of care for patients with inoperable esophageal cancer. However, patients tend to tolerate intravenous chemotherapy less well with age and comorbidities. It is essential to find a better treatment modality that improves survival outcomes without reducing the quality of life.ObjectiveTo evaluate the effectiveness of simultaneous integrated boost radiotherapy (SIB-RT) with concurrent and consolidated oral S-1 chemotherapy for patients aged 70 years and older with inoperable esophageal squamous cell carcinoma (ESCC).Design, Setting, and ParticipantsThis multicenter, phase III randomized clinical trial was conducted between March 2017 and April 2020 in 10 centers in China. Patients with inoperable, locally advanced, clinical stage II to IV ESCC were enrolled and randomized to receive SIB-RT concurrent with and followed by oral S-1 chemotherapy (CRTCT group) or SIB-RT alone (RT group). Data analysis was completed on March 22, 2022.InterventionsIn both groups, the planning gross tumor volume was administered with radiation dose of 59.92 Gy and the planning target volume was administered with radiation dose of 50.4 Gy, in 28 fractions each. In the CRTCT group, concurrent S-1 was administered on radiotherapy days, and consolidated S-1 was administered at 4 to 8 weeks after SIB-RT.Main Outcomes and MeasuresThe primary end point was overall survival (OS) of the intent-to-treat population. Secondary end points were progression-free survival (PFS) and toxicity profile.ResultsA total of 330 patients (median [IQR] age, 75.5 [72-79] years; 220 [66.7%] male patients) were included, with 146 patients randomized to the RT group and 184 randomized to the CRTCT group. A total of 107 patients (73.3%) in the RT group and 121 patients (67.9%) in the CRTCT group were clinically diagnosed with stage III to IV disease. At the time of analysis of the 330 patients in the intent-to treat-population (March 22, 2022), OS was improved in the CRTCT group compared with the RT group at 1 year (72.2% vs 62.3%) and 3 years (46.2% vs 33.9%; log-rank P = .02). PFS was similarly improved in the CRTCT group compared with the RT group at 1 year (60.8% vs 49.3%) and 3 years (37.3% vs 27.9%; log-rank P = .04). There was no significant difference in the incidence of treatment-related toxic effects higher than grade 3 between the 2 groups. Grade 5 toxic effects occurred in each group, including 1 patient who experienced myelosuppression and 4 patients with pneumonitis in the RT group and 3 patients with pneumonitis and 2 patients with fever in the CRTCT group.Conclusions and RelevanceThese findings suggest that oral S-1 chemotherapy administered with SIB-RT should be considered as an alternative treatment option for patients aged 70 years and older with inoperable ESCC, since it improved survival outcomes without additional treatment-related toxic effects compared with SIB-RT alone.Trial RegistrationClinicalTrials.gov Identifier: NCT02979691

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S-1–Based Chemoradiotherapy Followed by Consolidation Chemotherapy With S-1 in Elderly Patients With Esophageal Squamous Cell Carcinoma: A Multicenter Phase II Trial

Cited by 11 publications

References 50 publications

Radiotherapy combined with nimotuzumab for elderly esophageal cancer patients: A phase II clinical trial

Radiotherapy combined with nimotuzumab for elderly esophageal cancer patients: A phase II clinical trial

Treatment patterns and Outcomes of Elderly Patients with Potentially Curable Esophageal Cancer

Effectiveness of S-1–Based Chemoradiotherapy in Patients 70 Years and Older With Esophageal Squamous Cell Carcinoma

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