Induction chemotherapy followed by definitive chemoradiotherapy versus chemoradiotherapy alone in esophageal squamous cell carcinoma: a randomized phase II trial

Abstract

This randomized phase II trial aims to compare the efficacy and safety of induction chemotherapy followed by definitive chemoradiotherapy (CRT) versus CRT alone in patients with esophageal squamous cell carcinoma (ESCC) unsuitable for surgery (N = 110). The primary outcome was overall response rate (ORR), whereas the secondary outcome was overall survival. This trial did not meet pre-specified endpoints. The ORR was 74.5% in the induction chemotherapy group versus 61.8% in the CRT alone group (P = 0.152). The 3-year overall survival rate was 41.8% in the induction chemotherapy group and 38.1% in the CRT alone group (P = 0.584; hazard ratio, 0.88; 95% CI, 0.54–1.41). Grade 3–5 adverse events were similar. Patients who responded to induction chemotherapy had improved survival in the post-hoc analysis. These results demonstrate no improvement in response rate or survival with the addition of induction chemotherapy to CRT in unselected patients with ESCC. Trial number: NCT02403531.

Addition of Induction or Consolidation Chemotherapy in Definitive Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone for Patients With Unresectable Esophageal Cancer: A Systematic Review and Meta-Analysis

“…Liu et al. ( 14 ) also observed that patients who responded to IC had improved survival in the post-hoc analysis. Thirdly, histological types and tumor biological characteristics between ESCC and EAC are heterogeneous.…”

“…The 1-year OS rate was significantly higher in patients who were treated with IC-CCRT (HR 0.445, 95% CI 0.286–0.693; p < 0.001; Figure 2 ). In addition, three studies analyzed 3-year OS rate of the two groups ( 12 – 14 ). There was no significant difference in 2-year OS rate (HR 0.803, 95% CI 0.589–1.095; p = 0.166; Figure 2 ) and 3-year OS rate (HR 1.065, 95% CI 0.789–1.439; p = 0.680; Figure 2 ) between the two groups.…”

Induction Chemotherapy Followed by Chemoradiotherapy With or Without Consolidation Chemotherapy Versus Chemoradiotherapy Followed by Consolidation Chemotherapy for Esophageal Squamous Cell Carcinoma

“…A randomized phase II study suggested that the incidence of grades 3–4 neutropenia of preoperative I-CCRT using oxaliplatin/capecitabine or carboplatin/paclitaxel for resectable esophageal adenocarcinoma was 2.6% (1/38) and 21.4% [9/42] ( p = 0.011) ( 25 ). Another randomized phase II trial demonstrated that the incidence of grade 3 or 4 neutropenia of I-CCRT and CCRT alone with DP in ESCC was 18.2% and 7.3%, respectively ( p = 0.151) ( 26 ). There were no significant differences in rates of other grades 3–5 hematological adverse events between groups were observed ( 26 ).…”

“…Another randomized phase II trial demonstrated that the incidence of grade 3 or 4 neutropenia of I-CCRT and CCRT alone with DP in ESCC was 18.2% and 7.3%, respectively ( p = 0.151) ( 26 ). There were no significant differences in rates of other grades 3–5 hematological adverse events between groups were observed ( 26 ). Simoni et al.…”

Polyphenol-modified nanovesicles for synergistically enhanced in vitro tumor cell targeting and apoptosis

“…Chemotherapy destroys the cancer cells growing faster than healthy cells or inhibiting their metastasis. 1,2 Because this process occurs non-specifically, an additional attack on rapidly dividing normal cells is a fatal disadvantage. The limitations of conventional chemotherapy have led to the development of smart nanocarrier systems.…”