Randomized Trial of Preoperative Chemoradiation Versus Surgery Alone in Patients With Locoregional Esophageal Carcinoma

Urba, Susan G.; Orringer, Mark B.; Turrisi, Andrew T.; Iannettoni, Mark D.; Forastiere, Arlene A.; Strawderman, Myla

doi:10.1200/jco.2001.19.2.305

Cited by 1,182 publications

(748 citation statements)

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“…Twelve patients (median age 64 years; 67% male, 58% moderately differentiated, 83% esophageal, 100% HER2‐positive) received a median of 5.6 weeks of treatment (range: 1.1–8.4). Four patients underwent tumor resection and one of the four patients (25%) had a pCR, which was similar to the pCR rates of previously reported studies [1], [2], [3]. However, the number of patients evaluated in the present study was too low to make an accurate comparison with other studies.…”

supporting

confidence: 88%

“…Neoadjuvant chemoradiation therapy for patients with localized esophagogastric cancers has been the subject of much discussion and controversy, with conflicting results compared with surgery alone seen in previous randomized clinical trials [1], [2], [3]. Pathologic complete response (pCR) rates after neoadjuvant chemoradiation therapy are in the 25% range [1], [2], [3].…”

mentioning

confidence: 99%

“…Pathologic complete response (pCR) rates after neoadjuvant chemoradiation therapy are in the 25% range [1], [2], [3]. …”

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confidence: 99%

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A Phase II Study with Lead-In Safety Cohort of 5-Fluorouracil, Oxaliplatin, and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Treatment for Patients with Localized HER2-Positive Esophagogastric Adenocarcinomas

et al. 2017

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Lessons Learned.Neoadjuvant 5‐fluorouracil, oxaliplatin, and lapatinib in combination with radiation therapy is safe for neoadjuvant treatment for patients with localized human epidermal growth receptor 2‐positive esophagogastric adenocarcinoma.Evaluation of this drug combination in a larger patient pool would allow for more accurate analysis of its efficacy. Background.The optimal design of neoadjuvant chemoradiation for the treatment of localized esophagogastric cancers is the subject of much debate. In this nonrandomized trial, we evaluated neoadjuvant 5‐fluorouracil (5‐FU), oxaliplatin, and lapatinib in combination with radiation therapy as neoadjuvant treatment for patients with localized human epidermal growth receptor 2 (HER2)‐positive esophagogastric adenocarcinomas.Methods.Patients received neoadjuvant 5‐FU (225 mg/m2 continuous intravenous infusion, days 1–42), oxaliplatin (85 mg/m2 intravenously [IV], days 1, 15, and 29), and lapatinib (six patients, 1,000 mg p.o., days 1–42; six patients, 750 mg p.o., days 1–42) plus radiation (1.8 Gy/day Monday through Friday for 50.4 Gy total). Following restaging, eligible patients underwent definitive resection, and pathologic response to neoadjuvant therapy was assessed. Planned enrollment was 42 patients. The primary endpoint was the pathologic complete response (pCR) rate.Results.Twelve patients (median age 64 years; 67% male) received a median of 5.6 weeks of treatment (range: 1.1–8.4). The pCR rate was 8%; four of the 12 patients underwent tumor resection and one patient had a pCR, with pathologic partial response in the remaining three. The most common lapatinib‐related adverse events included (all grades) nausea (67%) and diarrhea (58%), although these were all grade 1 or 2. Enrollment was halted due to low accrual.Conclusion.The treatment regimen was determined to be safe. The study was terminated early due to low accrual.

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A Phase II Study with Lead-In Safety Cohort of 5-Fluorouracil, Oxaliplatin, and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Treatment for Patients with Localized HER2-Positive Esophagogastric Adenocarcinomas

et al. 2017

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“…[1][2][3][4][5][6] In the subset of patients with tumors of the gastroesophageal junction, CRT delivered postoperatively has also demonstrated a survival benefit. 7 To the best of our knowledge, no randomized controlled trials currently exist that compare the outcomes of the sequencing of CRT in relation to surgery in patients with esophageal cancer.…”

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confidence: 99%

The impact of radiation therapy sequencing on survival and cardiopulmonary mortality in the combined modality treatment of patients with esophageal cancer

Wojcieszynski

Berman²,

Wan³

et al. 2013

Cancer

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BACKGROUND: The addition of chemoradiation (CRT) to surgery has been shown to improve survival in patients with esophageal cancer. In the current study, the authors determined whether the sequencing of CRT has an effect on survival and cardiopulmonary mortality in patients with esophageal cancer. METHODS: Patients with the following inclusion criteria were identified within 17 Surveillance, Epidemiology, and End Results registries from 1988 through 2007: adenocarcinoma or squamous cell carcinoma of the esophagus and having undergone esophagectomy. Patients who died within 90 days of surgery were excluded. Demographic, tumor, and survival data were compared between patients receiving preoperative and postoperative RT. Cox proportional hazards regression models were calculated to identify parameters associated with cause-specific survival and overall survival. A competing risk analysis was performed to account for death due to esophageal cancer in the calculation of cardiopulmonary mortality. RESULTS: Of 5512 patients, 1881 received preoperative RT, 901 received postoperative RT, and 2730 did not receive RT. Patients receiving preoperative RT had improved 5-year cause-specific survival (41% vs 31%; P < .0001) and overall survival (33% vs 23%; P < .0001) compared with those receiving postoperative RT. No differences in adjusted cardiopulmonary mortality were found between patients who received RT versus those who did not (8% vs 10% at 10 years; hazards ratio [HR] KEYWORDS: esophageal neoplasms, combined modality therapy, radiation oncology, survival, heart diseases, lung diseases. INTRODUCTIONIn patients with locally advanced esophageal cancer, the addition of chemoradiation (CRT) to surgery has shown improvements in overall survival (OS) when given preoperatively. [1][2][3][4][5][6] In the subset of patients with tumors of the gastroesophageal junction, CRT delivered postoperatively has also demonstrated a survival benefit. 7 To the best of our knowledge, no randomized controlled trials currently exist that compare the outcomes of the sequencing of CRT in relation to surgery in patients with esophageal cancer.Preoperative CRT is preferred over postoperative treatment in patients with other gastrointestinal malignancies such as rectal cancer, in whom preoperative CRT has been demonstrated to have a superior locoregional control rate, toxicity profile, and survival rate. 8,9 It is postulated that preoperative treatment is favored because of tumor downstaging and smaller radiation treatment fields. We hypothesized that preoperative RT is associated with decreased cardiopulmonary mortality from lower RT doses to the heart and lungs as well as improved survival outcomes compared with postoperative RT in patients with esophageal cancer.Using the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) database, we assessed differences in survival outcomes between patients treated with preoperative RT and those treated with postoperative RT and analyzed the effect of RT on heart and lung morbidity a...

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“…Subset analyses demonstrate that only true complete responders have a durable diseasefree and overall survival benefit. [26][27][28][29] The addition of gene therapy to currently employed modalities of chemotherapy, radiotherapy and surgery attempts to enhance the overall antitumor efficacy and increase the number of complete responders. It has been reported that MUC1 is expressed in as high as 43% of esophageal adenocarcinoma specimens and that a majority of these specimens were poorly differentiated advanced neoplasms.…”

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confidence: 99%

Selective gene expression using a DF3/MUC1 promoter in a human esophageal adenocarcinoma model

et al. 2003

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Randomized Trial of Preoperative Chemoradiation Versus Surgery Alone in Patients With Locoregional Esophageal Carcinoma

Abstract: This randomized trial of preoperative chemoradiation versus surgery alone for patients with potentially resectable esophageal carcinoma did not demonstrate a statistically significant survival difference.

Cited by 1,182 publications

References 16 publications

A Phase II Study with Lead-In Safety Cohort of 5-Fluorouracil, Oxaliplatin, and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Treatment for Patients with Localized HER2-Positive Esophagogastric Adenocarcinomas

A Phase II Study with Lead-In Safety Cohort of 5-Fluorouracil, Oxaliplatin, and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Treatment for Patients with Localized HER2-Positive Esophagogastric Adenocarcinomas

The impact of radiation therapy sequencing on survival and cardiopulmonary mortality in the combined modality treatment of patients with esophageal cancer

Selective gene expression using a DF3/MUC1 promoter in a human esophageal adenocarcinoma model

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