Toxicity, Response Rates and Survival Outcomes of Induction Cisplatin and Irinotecan Followed by Concurrent Cisplatin, Irinotecan and Radiotherapy for Locally Advanced Esophageal Cancer

Watkins, John M.; Zauls, A. Jason; Kearney, Patricia L.; Shirai, Keisuke; Ruppert, Bree N.; Harper, Jennifer L.; Sherman, Carol A.; Aguero, Eric G.; Reed, Carolyn E.; Sharma, Anand K.

doi:10.1093/jjco/hyq208

Cited by 8 publications

(6 citation statements)

References 20 publications

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“…39,40 Midway during the decade, the concomitant administration of the chimeric monocloncal antibody against the EGFR, cetuximab, and ionizing radiation, was shown to yield a superior survival outcome in patients with head and neck cancer. 23,24 …”

Section: Discussionmentioning

confidence: 99%

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Cetuximab Plus Cisplatin, Irinotecan, and Thoracic Radiotherapy as Definitive Treatment for Locally Advanced, Unresectable Esophageal Cancer: A Phase-II Study of The SWOG (S0414)

Tomblyn

Goldman

Thomas

et al. 2012

Journal of Thoracic Oncology

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Introduction The specific aims of the study were to evaluate the two-year overall survival (OS) and progression-free survival (PFS), toxicity profile, and best objective response rate in patients with locally advanced, clinically unresectable esophageal cancer receiving cetuximab, cisplatin, irinotecan, and thoracic radiotherapy (TRT) within a multi-institutional cooperative group setting. Methods Eligible patients (cT4 M0 or medically unresectable, biopsy proven, non-cervical esophageal cancer) were to receive four 21-day cycles of cetuximab 400 mg/m2 (days 1, cycle 1), cetuximab 250 mg/m2 (days 8, 15, cycle 1; then days 1, 8, 15 for subsequent cycles), cisplatin 30 mg/m2 (days 1, 8 all cycles), and irinotecan 65 mg/m2 (days 1, 8 all cycles). TRT was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, to begin with day 1, cycle 3. The primary endpoint was 2-year OS, with an accrual goal of 75 patients with adenocarcinoma. Results The study was closed due to slow accrual, with 21 eligible patients (11 squamous, 10 adenocarcinoma) enrolled from May 2005 to September 2007. Two-year OS and PFS (95% CI) were 33.3% (14.6–57.0%) and 23.8% (8.2–47.2%), respectively. Kaplan-Meier estimates of median (95% CI) OS and PFS were 11.2 (6.4–43.6) and 6.4 (3.7–12.0) months, respectively. The overall response rate (95% CI) among 17 evaluable patients was 17.6% (3.8–43.4%), including 6% confirmed complete responders and 12% unconfirmed partial responders. Two deaths were due to protocol treatment (sudden death & GI necrosis). Ten (47.6%) and 6 (28.6%) patients had Grade 3/4 toxicity, respectively: 52.4% hematologic, 23.8% fatigue, 19.0% nausea, 19.0% dehydration, and 19.0% anorexia. Conclusions Concomitant cetuximab, cisplatin, irinotecan, and TRT was poorly tolerated in the first North American cooperative group trial testing this regimen for locally advanced esophageal cancer, as treatment-related mortality approached 10%. Single institution phase II cetuximab-based combined modality trials have yielded encouraging results in preliminary analyses. The SWOG GI Committee endorses enrollment to open clinical trials in order to clarify the therapeutic ratio of cetuximab-based combined modality approaches for esophageal cancer.

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Section: Discussionmentioning

confidence: 99%

“…A retrospective analysis of induction cisplatin and irinotecan followed by concurrent cisplatin, irinotecan, and TRT with a median follow-up of two years reported a 2-year OS of 42% and acceptable tolerability of this regimen. 24 …”

Section: Introductionmentioning

confidence: 99%

Cetuximab Plus Cisplatin, Irinotecan, and Thoracic Radiotherapy as Definitive Treatment for Locally Advanced, Unresectable Esophageal Cancer: A Phase-II Study of The SWOG (S0414)

Tomblyn

Goldman

Thomas

et al. 2012

Journal of Thoracic Oncology

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“…A multicenter phase II FFCD trial 19 reported that induction chemotherapy with cisplatin and irinotecan followed by CCRT without surgery for stage I-III EC resulted in CR of 58.1% and 1-and 2-years OS of 62.8% and 27.9%, respectively. Watkins et al 21 reported that induction cisplatin and irinotecan followed by concurrent cisplatin, irinotecan and radiotherapy for locally advanced esophageal cancer is tolerable with 2-year OS of 42% and 2-year PFS 9%. A prospective, multicenter phase I/II study 16 reported that induction chemotherapy with docetaxel, cisplatin and uorouracil followed by CCRT was tolerable, with the CR of 39.4 %, the median PFS of 12.2 months and the median OS of 26.0 months in unresectable locally advanced ESCC.…”

Section: Prognostic Factorsmentioning

confidence: 99%

Induction chemotherapy followed by chemoradiotherapy with or without consolidation chemotherapy versus Chemoradiotherapy followed by consolidation chemotherapy for Esophageal Squamous Cell Carcinoma

Xiang

Han

Liu

et al. 2021

Preprint

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Purpose To compare the efficacy and safety of induction chemotherapy followed by concurrent chemoradiotherapy(I-CCRT), induction chemotherapy followed by concurrent chemoradiotherapy and consolidation chemotherapy(I-CCRT-C), and concurrent chemoradiotherapy followed by consolidation chemotherapy(CCRT-C) for locally advanced esophageal squamous cell carcinoma(ESSC). Methods Patients with locally advanced ESCC who underwent definitive chemoradiotherapy with cisplatin plus fluorouracil or docetaxel from February 2012 to December 2018 were retrospectively reviewed. Kaplan-Meier curve was used to estimate survival. Efficacy was assessed using RECIST, version 1.0. Prognosis factors were identified with Cox regression analysis. Results Patients were treated with CCRT-C(n=59), I-CCRT(n=20), and I-CCRT-C(n=48), SCRT(n=119). The median follow-up duration was 73.9 months for the entire cohort. The ORR of the CCRT-C, I-CCRT, and I-CCRT-C, SCRT groups was 89.8%, 70.0%, and 77.1%, respectively ( P = 0.078). The median PFS in the CCRT-C, I-CCRT, and I-CCRT-C groups was 32.5, 16.1, and 27.1 months, respectively ( P = 0.464). The median OS of the CCRT-C, I-CCRT, and I-CCRT-C groups was 45.9, 35.5, and 54.0 months, respectively ( P = 0.788). Cox regression analysis indicated that I-CCRT and I-CCRT had comparable PFS and OS with CCRT-C( P > 0.05). Neutropenia grade ≥ 3 in CCRT-C, I-CCRT, I-CCRT-C, and SCRT groups was 47.5%, 15%, and 33.3% of patients, respectively( P =0.027). Conclusions I-CCRT and I-CCRT-C using cisplatin plus fluorouracil or docetaxel regimen had comparable outcomes with CCRT-C for locally advanced ESCC. I-CCRT and I-CCRT-C seem to have less severe neutropenia than CCRT-C, and potential to be a standard treatment option for locally advanced ESCC.

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“…Chemoradiation regimens using paclitaxel (Goldberg et al, 2003;Bains et al, 2002;Orditura et al, 2010;Ruppert et al, 2010), docetaxel (Pasini et al, 2005;Spigel et al, 2010), irinotecan (Ruppert et al, 2010;Ilson et al, 2002;Watkins et al, 2011;Sun et al, 2011), oxaliplatin (Spigel et al, 2010;De Vita et al, 2011;Chiarion-Sileni et al, 2009), epirubicin (Sun et al, 2011) and pemetrexed (Jatoi et al, 2010) have shown encouraging results. Biologic agents, such as cetuximab, trastuzumab, erlotinib, celecoxib and bevacizumab (De Vita et al, 2011;Safran et al, 2002;Enzinger et al, 2003;Suntharalingam et al, 2006) are being used as the foundations for new regimens which may enhance chemoradiation and target systemic micrometastases.…”

Section: New Combined Modality Regimensmentioning

confidence: 99%

Nonsurgical Management of Esophageal Cancer

Safa¹,

Reda²

2012

Esophageal Cancer - Cell and Molecular Biology, Biomarkers, Nutrition and Treatment

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Toxicity, Response Rates and Survival Outcomes of Induction Cisplatin and Irinotecan Followed by Concurrent Cisplatin, Irinotecan and Radiotherapy for Locally Advanced Esophageal Cancer

Abstract: Cisplatin/irinotecan chemoradiotherapy is tolerable, demonstrating similar efficacy for squamous cell and adenocarcinoma esophageal cancers.

Cited by 8 publications

References 20 publications

Cetuximab Plus Cisplatin, Irinotecan, and Thoracic Radiotherapy as Definitive Treatment for Locally Advanced, Unresectable Esophageal Cancer: A Phase-II Study of The SWOG (S0414)

Cetuximab Plus Cisplatin, Irinotecan, and Thoracic Radiotherapy as Definitive Treatment for Locally Advanced, Unresectable Esophageal Cancer: A Phase-II Study of The SWOG (S0414)

Induction chemotherapy followed by chemoradiotherapy with or without consolidation chemotherapy versus Chemoradiotherapy followed by consolidation chemotherapy for Esophageal Squamous Cell Carcinoma

Nonsurgical Management of Esophageal Cancer

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