INT 0123 (Radiation Therapy Oncology Group 94-05) Phase III Trial of Combined-Modality Therapy for Esophageal Cancer: High-Dose Versus Standard-Dose Radiation Therapy

Minsky, Bruce D.; Pajak, Thomas F.; Ginsberg, Robert J.; Pisansky, Thomas M.; Martenson, James A.; Komaki, Ritsuko; Okawara, Gordon; Rosenthal, Seth A.; Kelsen, David P.

doi:10.1200/jco.2002.20.5.1167

Cited by 950 publications

(369 citation statements)

References 10 publications

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“…9,10 Trials of CRT alone report survival rates of 25% to 40%, [11][12][13] which is similar to rates reported for trimodality…”

Section: Introductionsupporting

confidence: 68%

“…Although the benefit of surgical resection after CRT is equivocal in terms of OS, there is clear benefit in terms of local control. In randomized trials, the local recurrence rate for patients treated with CRT is dismal, ranging from 40% to 60%, 9-11, 13 and there is a statistically significant improvement in local control with resection. Given the uncertain survival benefit and the morbidity and mortality of surgical resection after CRT and the high local failure rate if surgery is omitted, there is growing interest in developing criteria to identify patients who may safely defer surgery after CRT.…”

Section: Discussionmentioning

confidence: 99%

“…Despite this, strategies forgoing resection may be inappropriate for many patients because local failure rates for CRT alone can exceed 50%, 9,10, 13 and there is evidence that resection after CRT improves local control.…”

Section: Journal Of Clinical Oncology O R I G I N a L R E P O R T V Omentioning

confidence: 99%

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Outcomes of Patients With Esophageal Cancer Staged With [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET): Can Postchemoradiotherapy FDG-PET Predict the Utility of Resection?

Monjazeb

Riedlinger

Aklilu

et al. 2010

JCO

118

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Purpose To determine whether [18F]fluorodeoxyglucose positron emission tomography (FDG-PET) can delineate patients with esophageal cancer who may not benefit from esophagectomy after chemoradiotherapy. Patients and Methods We reviewed records of 163 patients with histologically confirmed stage I to IVA esophageal cancer receiving chemoradiotherapy with or without resection with curative intent. All patients received surgical evaluation. Initial and postchemoradiotherapy FDG-PET scans and prognostic/treatment variables were analyzed. FDG-PET complete response (PET-CR) after chemoradiotherapy was defined as standardized uptake value ≤ 3. Results Eighty-eight patients received trimodality therapy and 75 received chemoradiotherapy. Surgery was deferred primarily due to medical inoperability or unresectable/metastatic disease after chemoradiotherapy. A total of 105 patients were evaluable for postchemoradiotherapy FDG-PET response. Thirty-one percent achieved a PET-CR. PET-CR predicted for improved outcomes for chemoradiotherapy (2-year overall survival, 71% v 11%, P < .01; 2-year freedom from local failure [LFF], 75% v 28%, P < .01), but not trimodality therapy. On multivariate analysis of patients treated with chemoradiotherapy, PET-CR is the strongest independent prognostic variable (survival hazard ratio [HR], 9.82, P < .01; LFF HR, 14.13, P < .01). PET-CR predicted for improved outcomes regardless of histology, although patients with adenocarcinoma achieved a PET-CR less often. Conclusion Patients treated with trimodality therapy found no benefit with PET-CR, likely because FDG-PET residual disease was resected. Definitive chemoradiotherapy patients achieving PET-CR had excellent outcomes equivalent to trimodality therapy despite poorer baseline characteristics. Patients who achieve a PET-CR may not benefit from added resection given their excellent outcomes without resection. These results should be validated in a prospective trial of FDG-PET–directed therapy for esophageal cancer.

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“…9,10 Trials of CRT alone report survival rates of 25% to 40%, [11][12][13] which is similar to rates reported for trimodality…”

Section: Introductionsupporting

confidence: 68%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Outcomes of Patients With Esophageal Cancer Staged With [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET): Can Postchemoradiotherapy FDG-PET Predict the Utility of Resection?

Monjazeb

Riedlinger

Aklilu

et al. 2010

JCO

118

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“…The median OS in this study was 23.7 months, which was better when compared with the 14.1 month median OS in the CCRT group of the RTOG 85‐01 trial 3 and the 13 month median OS in high‐dose group of the RTOG 94‐05 trial 18 . The survival outcomes in our study were also comparable to latest results from other clinical trials in the CCRT setting with modern chemotherapy regimens.…”

Section: Discussionmentioning

confidence: 47%

Long‐term results of definitive concurrent chemoradiotherapy using paclitaxel plus oxaliplatin in unresectable locally advanced esophageal cancer: a prospective phase II trial

et al. 2016

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This prospective study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients. Between January 2006 and December 2010, 34 patients with unresectable locally advanced esophageal cancer were enrolled in this study. Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent PTX (135 mg/m², d 1) and OHP (130 mg/m², d 1) were administered on Day 1 and Day 29 of radiotherapy. Of these patients, 76.5% completed the treatment course with a response rate of 73.5%, including eight (23.5%) patients with complete response and 17 (50.0%) patients with partial response. The median overall survival (OS) time was 23.7 months (range: 4.0–65.5 months) with 1‐, 3‐ and 5‐year OS rates were 64.3%, 36.6% and 25.8%, respectively. The median progression‐free survival (PFS) time was 21.2 months with 1‐, 3‐ and 5‐year PFS rates were 63.8%, 30.9% and 20.4%, respectively, During the CCRT course, the main grade 3 or greater acute toxicities were leukopenia (38.2%), esophagitis (14.7%), and dysphagia (11.8%), with late toxicity being infrequent. Although this study did not meet its primary endpoint, the application of CCRT with PTX and OHP in unresectable locally advanced esophageal carcinoma yielded satisfactory clinical outcomes and manageable toxicities.

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“…1 According to a series of studies implemented by the Radiation Therapy Oncology Group (RTOG), such as the RTOG 8501 2 and RTOG 9405, 3 concurrent chemoradiotherapy (CCRT) was established as a standard approach for locally advanced EC; however, the prognosis was still poor with a median overall survival (OS) of 14.1 and 18.1 months, respectively. In order to improve the prognosis, late-course accelerated hyperfractionated (LCAF) radiotherapy (RT) was scheduled on oesophageal squamous cell carcinoma (ESCC) by Shi et al 4 in 1999.…”

mentioning

confidence: 99%

Phase II study of concurrent selective lymph node late course accelerated hyper-fractionated radiotherapy and pemetrexed and cisplatin for locally advanced oesophageal squamous cell carcinoma

Guo

et al. 2014

The British Journal of Radiology

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Objective: To determine the clinical efficacy and toxicity of pemetrexed combined with low-dose cisplatin (CDDP) concurrent with late-course accelerated hyperfractionated (LCAF) intensity-modulated radiation therapy (IMRT) in patients with inoperable locally advanced oesophageal squamous cell carcinoma (ESCC). Methods: Patients with locally advanced ESCC (less than or equal to 75 years of age, clinical stages IIB-IVA and Karnofsky performance status $70) were enrolled into the study. A target group size of 22 was projected based on the estimation that 2-year overall survival (OS) would increase from 20% to 40%. Patients were treated with pemetrexed, low-dose CDDP and LCAF IMRT concurrently. The main objective of the study was for a 2-year OS, and the secondary objectives were progression-free survival (PFS), objective response, locoregional failure rate, and acute and late toxicities.Results: 25 patients were recruited from October 2008 to July 2011. The median OS was 21 months, with 2-and 5-year OS rates of 44% and 44%, respectively. The median PFS was 18.2 months. The objective response rate was 96% (24/25), with 11 complete responses and 13 partial responses. The locoregional failure rate was 16%. Grades 4 and 5 acute toxicity rates were 8% and 4%, respectively, while no Grade 3 or greater late toxicity was observed. Conclusion: The findings of this Phase II study indicated that the therapeutic regimen appears to achieve an excellent response rate and favourable survival for locally advanced ESCC. However, the severe acute side effects should be considered cautiously in further studies. Advances in knowledge: To our knowledge, this is the first study that introduced pemetrexed and low-dose CDDP combined with LCAF IMRT to treat locally advanced ESCC. The 5-year OS rate was as high as 44%, which was more favourable than other studies.Oesophageal carcinoma (EC) is one of the common malignant tumours all over the world, with China having a high incidence, for about 150,000 people die of it each year, accounting for nearly a quarter of all cancer deaths worldwide.1 According to a series of studies implemented by the Radiation Therapy Oncology Group (RTOG), such as the RTOG 8501 2 and RTOG 9405, 3 concurrent chemoradiotherapy (CCRT) was established as a standard approach for locally advanced EC; however, the prognosis was still poor with a median overall survival (OS) of 14.1 and 18.1 months, respectively. In order to improve the prognosis, late-course accelerated hyperfractionated (LCAF) radiotherapy (RT) was scheduled on oesophageal squamous cell carcinoma (ESCC) by Shi et al 4 in 1999. The results of LCAF RT were encouraging, with the 5-year survival rate varying from 26% to 33%. [4][5][6] Furthermore, patients with ESCC who were treated with concurrent LCAF RT and chemotherapy had a 5-year survival rate of 40% and a median survival time of 30.8 months in the study by Zhao et al. 7 Therefore, this study indicated better survival in patients who received concurrent LCAF RT and chemotherapy than in those rece...

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INT 0123 (Radiation Therapy Oncology Group 94-05) Phase III Trial of Combined-Modality Therapy for Esophageal Cancer: High-Dose Versus Standard-Dose Radiation Therapy

Cited by 950 publications

References 10 publications

Outcomes of Patients With Esophageal Cancer Staged With [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET): Can Postchemoradiotherapy FDG-PET Predict the Utility of Resection?

Outcomes of Patients With Esophageal Cancer Staged With [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET): Can Postchemoradiotherapy FDG-PET Predict the Utility of Resection?

Long‐term results of definitive concurrent chemoradiotherapy using paclitaxel plus oxaliplatin in unresectable locally advanced esophageal cancer: a prospective phase II trial

Phase II study of concurrent selective lymph node late course accelerated hyper-fractionated radiotherapy and pemetrexed and cisplatin for locally advanced oesophageal squamous cell carcinoma

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INT 0123 (Radiation Therapy Oncology Group 94-05) Phase III Trial of Combined-Modality Therapy for Esophageal Cancer: High-Dose Versus Standard-Dose Radiation Therapy

Cited by 950 publications

References 10 publications

Outcomes of Patients With Esophageal Cancer Staged With [18F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET): Can Postchemoradiotherapy FDG-PET Predict the Utility of Resection?

Outcomes of Patients With Esophageal Cancer Staged With [18F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET): Can Postchemoradiotherapy FDG-PET Predict the Utility of Resection?

Long‐term results of definitive concurrent chemoradiotherapy using paclitaxel plus oxaliplatin in unresectable locally advanced esophageal cancer: a prospective phase II trial

Phase II study of concurrent selective lymph node late course accelerated hyper-fractionated radiotherapy and pemetrexed and cisplatin for locally advanced oesophageal squamous cell carcinoma

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Product

Resources

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Outcomes of Patients With Esophageal Cancer Staged With [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET): Can Postchemoradiotherapy FDG-PET Predict the Utility of Resection?

Outcomes of Patients With Esophageal Cancer Staged With [¹⁸F]Fluorodeoxyglucose Positron Emission Tomography (FDG-PET): Can Postchemoradiotherapy FDG-PET Predict the Utility of Resection?