NRG Oncology/RTOG 0921: A phase 2 study of postoperative intensity-modulated radiotherapy with concurrent cisplatin and bevacizumab followed by carboplatin and paclitaxel for patients with endometrial cancer

Akila N. Viswanathan, Jennifer Moughan, Brigitte E. Miller, Ying Xiao, Anuja Jhingran, Lorraine Portelance, Walter R. Bosch, Ursula A. Matulonis, Neil S. Horowitz, Robert S. Mannel, Luis Souhami, Beth A. Erickson, Kathryn A. Winter, William Small, David K. Gaffney

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

BACKGROUND The current study was conducted to assess acute and late adverse events (AEs), overall survival (OS), pelvic failure, regional failure, distant failure, and disease-free survival in a prospective phase 2 clinical trial of bevacizumab and pelvic intensity-modulated radiotherapy (IMRT) with chemotherapy in patients with high-risk endometrial cancer. METHODS Patients underwent a hysterectomy and lymph node removal, and had ≥1 of the following high-risk factors: grade 3 carcinoma with >50% myometrial invasion, grade 2 or 3 disease with any cervical stromal invasion, or known extrauterine extension confined to the pelvis. Treatment included pelvic IMRT and concurrent cisplatin on days 1 and 29 of radiation and bevacizumab (at a dose of 5 mg/kg on days 1, 15, and 29 of radiation) followed by adjuvant carboplatin and paclitaxel for 4 cycles. The primary endpoint was grade ≥3 AEs occurring within the first 90 days (toxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). RESULTS A total of 34 patients were accrued from November 2009 through December 2011, 30 of whom were eligible and received study treatment. Seven of 30 patients (23.3%; 1-sided 95% confidence interval, 10.6%-36.0%) developed grade ≥3 treatment-related nonhematologic toxicities within 90 days; an additional 6 patients experienced grade ≥3 toxicities between 90 and 365 days after treatment. The 2-year OS rate was 96.7% and the disease-free survival rate was 79.1%. No patient developed a within-field pelvic failure and no patients with International Federation of Gynecology and Obstetrics stage I to IIIA disease developed disease recurrence after a median follow-up of 26 months. CONCLUSIONS Postoperative bevacizumab added to chemotherapy and pelvic IMRT appears to be well tolerated and results in high OS rates at 2 years for patients with high-risk endometrial carcinoma. Cancer 2015;121:2156-2163.

Original languageEnglish (US)
Pages (from-to)2156-2163
Number of pages8
JournalCancer
Volume121
Issue number13
DOIs
StatePublished - Jul 1 2015

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Intensity-Modulated Radiotherapy
Carboplatin
Endometrial Neoplasms
Paclitaxel
Cisplatin
Survival Rate
Disease-Free Survival
Radiation
Drug Therapy
National Cancer Institute (U.S.)
Bevacizumab
Therapeutics
Hysterectomy
Pelvis
Gynecology
Terminology
Obstetrics
Lymph Nodes
Clinical Trials
Confidence Intervals

Keywords

  • bevacizumab
  • chemotherapy
  • endometrial cancer
  • intensity-modulated radiotherapy (IMRT)
  • radiation

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

NRG Oncology/RTOG 0921 : A phase 2 study of postoperative intensity-modulated radiotherapy with concurrent cisplatin and bevacizumab followed by carboplatin and paclitaxel for patients with endometrial cancer. / Viswanathan, Akila N.; Moughan, Jennifer; Miller, Brigitte E.; Xiao, Ying; Jhingran, Anuja; Portelance, Lorraine; Bosch, Walter R.; Matulonis, Ursula A.; Horowitz, Neil S.; Mannel, Robert S.; Souhami, Luis; Erickson, Beth A.; Winter, Kathryn A.; Small, William; Gaffney, David K.

In: Cancer, Vol. 121, No. 13, 01.07.2015, p. 2156-2163.

Research output: Contribution to journalArticle

Viswanathan, AN, Moughan, J, Miller, BE, Xiao, Y, Jhingran, A, Portelance, L, Bosch, WR, Matulonis, UA, Horowitz, NS, Mannel, RS, Souhami, L, Erickson, BA, Winter, KA, Small, W & Gaffney, DK 2015, 'NRG Oncology/RTOG 0921: A phase 2 study of postoperative intensity-modulated radiotherapy with concurrent cisplatin and bevacizumab followed by carboplatin and paclitaxel for patients with endometrial cancer', Cancer, vol. 121, no. 13, pp. 2156-2163. https://doi.org/10.1002/cncr.29337
Viswanathan, Akila N. ; Moughan, Jennifer ; Miller, Brigitte E. ; Xiao, Ying ; Jhingran, Anuja ; Portelance, Lorraine ; Bosch, Walter R. ; Matulonis, Ursula A. ; Horowitz, Neil S. ; Mannel, Robert S. ; Souhami, Luis ; Erickson, Beth A. ; Winter, Kathryn A. ; Small, William ; Gaffney, David K. / NRG Oncology/RTOG 0921 : A phase 2 study of postoperative intensity-modulated radiotherapy with concurrent cisplatin and bevacizumab followed by carboplatin and paclitaxel for patients with endometrial cancer. In: Cancer. 2015 ; Vol. 121, No. 13. pp. 2156-2163.
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abstract = "BACKGROUND The current study was conducted to assess acute and late adverse events (AEs), overall survival (OS), pelvic failure, regional failure, distant failure, and disease-free survival in a prospective phase 2 clinical trial of bevacizumab and pelvic intensity-modulated radiotherapy (IMRT) with chemotherapy in patients with high-risk endometrial cancer. METHODS Patients underwent a hysterectomy and lymph node removal, and had ≥1 of the following high-risk factors: grade 3 carcinoma with >50{\%} myometrial invasion, grade 2 or 3 disease with any cervical stromal invasion, or known extrauterine extension confined to the pelvis. Treatment included pelvic IMRT and concurrent cisplatin on days 1 and 29 of radiation and bevacizumab (at a dose of 5 mg/kg on days 1, 15, and 29 of radiation) followed by adjuvant carboplatin and paclitaxel for 4 cycles. The primary endpoint was grade ≥3 AEs occurring within the first 90 days (toxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). RESULTS A total of 34 patients were accrued from November 2009 through December 2011, 30 of whom were eligible and received study treatment. Seven of 30 patients (23.3{\%}; 1-sided 95{\%} confidence interval, 10.6{\%}-36.0{\%}) developed grade ≥3 treatment-related nonhematologic toxicities within 90 days; an additional 6 patients experienced grade ≥3 toxicities between 90 and 365 days after treatment. The 2-year OS rate was 96.7{\%} and the disease-free survival rate was 79.1{\%}. No patient developed a within-field pelvic failure and no patients with International Federation of Gynecology and Obstetrics stage I to IIIA disease developed disease recurrence after a median follow-up of 26 months. CONCLUSIONS Postoperative bevacizumab added to chemotherapy and pelvic IMRT appears to be well tolerated and results in high OS rates at 2 years for patients with high-risk endometrial carcinoma. Cancer 2015;121:2156-2163.",
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T2 - A phase 2 study of postoperative intensity-modulated radiotherapy with concurrent cisplatin and bevacizumab followed by carboplatin and paclitaxel for patients with endometrial cancer

AU - Viswanathan, Akila N.

AU - Moughan, Jennifer

AU - Miller, Brigitte E.

AU - Xiao, Ying

AU - Jhingran, Anuja

AU - Portelance, Lorraine

AU - Bosch, Walter R.

AU - Matulonis, Ursula A.

AU - Horowitz, Neil S.

AU - Mannel, Robert S.

AU - Souhami, Luis

AU - Erickson, Beth A.

AU - Winter, Kathryn A.

AU - Small, William

AU - Gaffney, David K.

PY - 2015/7/1

Y1 - 2015/7/1

N2 - BACKGROUND The current study was conducted to assess acute and late adverse events (AEs), overall survival (OS), pelvic failure, regional failure, distant failure, and disease-free survival in a prospective phase 2 clinical trial of bevacizumab and pelvic intensity-modulated radiotherapy (IMRT) with chemotherapy in patients with high-risk endometrial cancer. METHODS Patients underwent a hysterectomy and lymph node removal, and had ≥1 of the following high-risk factors: grade 3 carcinoma with >50% myometrial invasion, grade 2 or 3 disease with any cervical stromal invasion, or known extrauterine extension confined to the pelvis. Treatment included pelvic IMRT and concurrent cisplatin on days 1 and 29 of radiation and bevacizumab (at a dose of 5 mg/kg on days 1, 15, and 29 of radiation) followed by adjuvant carboplatin and paclitaxel for 4 cycles. The primary endpoint was grade ≥3 AEs occurring within the first 90 days (toxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). RESULTS A total of 34 patients were accrued from November 2009 through December 2011, 30 of whom were eligible and received study treatment. Seven of 30 patients (23.3%; 1-sided 95% confidence interval, 10.6%-36.0%) developed grade ≥3 treatment-related nonhematologic toxicities within 90 days; an additional 6 patients experienced grade ≥3 toxicities between 90 and 365 days after treatment. The 2-year OS rate was 96.7% and the disease-free survival rate was 79.1%. No patient developed a within-field pelvic failure and no patients with International Federation of Gynecology and Obstetrics stage I to IIIA disease developed disease recurrence after a median follow-up of 26 months. CONCLUSIONS Postoperative bevacizumab added to chemotherapy and pelvic IMRT appears to be well tolerated and results in high OS rates at 2 years for patients with high-risk endometrial carcinoma. Cancer 2015;121:2156-2163.

AB - BACKGROUND The current study was conducted to assess acute and late adverse events (AEs), overall survival (OS), pelvic failure, regional failure, distant failure, and disease-free survival in a prospective phase 2 clinical trial of bevacizumab and pelvic intensity-modulated radiotherapy (IMRT) with chemotherapy in patients with high-risk endometrial cancer. METHODS Patients underwent a hysterectomy and lymph node removal, and had ≥1 of the following high-risk factors: grade 3 carcinoma with >50% myometrial invasion, grade 2 or 3 disease with any cervical stromal invasion, or known extrauterine extension confined to the pelvis. Treatment included pelvic IMRT and concurrent cisplatin on days 1 and 29 of radiation and bevacizumab (at a dose of 5 mg/kg on days 1, 15, and 29 of radiation) followed by adjuvant carboplatin and paclitaxel for 4 cycles. The primary endpoint was grade ≥3 AEs occurring within the first 90 days (toxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0]). RESULTS A total of 34 patients were accrued from November 2009 through December 2011, 30 of whom were eligible and received study treatment. Seven of 30 patients (23.3%; 1-sided 95% confidence interval, 10.6%-36.0%) developed grade ≥3 treatment-related nonhematologic toxicities within 90 days; an additional 6 patients experienced grade ≥3 toxicities between 90 and 365 days after treatment. The 2-year OS rate was 96.7% and the disease-free survival rate was 79.1%. No patient developed a within-field pelvic failure and no patients with International Federation of Gynecology and Obstetrics stage I to IIIA disease developed disease recurrence after a median follow-up of 26 months. CONCLUSIONS Postoperative bevacizumab added to chemotherapy and pelvic IMRT appears to be well tolerated and results in high OS rates at 2 years for patients with high-risk endometrial carcinoma. Cancer 2015;121:2156-2163.

KW - bevacizumab

KW - chemotherapy

KW - endometrial cancer

KW - intensity-modulated radiotherapy (IMRT)

KW - radiation

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