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Neoadjuvant chemoradiation for distal rectal cancer: 5-year updated results of a randomized phase 2 study of neoadjuvant combined modality chemoradiation for distal rectal cancer.

Publication ,  Journal Article
Mohiuddin, M; Paulus, R; Mitchell, E; Hanna, N; Yuen, A; Nichols, R; Yalavarthi, S; Hayostek, C; Willett, C
Published in: Int J Radiat Oncol Biol Phys
July 1, 2013

PURPOSE: To assess the efficacy of 2 different approaches to neoadjuvant chemoradiation for distal rectal cancers. METHODS AND MATERIALS: One hundred six patients with T3/T4 distal rectal cancers were randomized in a phase 2 study. Patients received either continuous venous infusion (CVI) of 5-Fluorouracil (5-FU), 225 mg/m(2) per day, 7 days per week plus pelvic hyperfractionated radiation (HRT), 45.6 Gy at 1.2 Gy twice daily plus a boost of 9.6 to 14.4 Gy for T3 or T4 cancers (Arm 1), or CVI of 5-FU, 225 mg/m(2) per day, Monday to Friday, plus irinotecan, 50 mg/m(2) once weekly × 4, plus pelvic radiation therapy (RT), 45 Gy at 1.8 Gy per day and a boost of 5.4 Gy for T3 and 9 Gy for T4 cancers (Arm 2). Surgery was performed 4 to 10 weeks later. RESULTS: All eligible patients (n=103) are included in this analysis; 2 ineligible patients were excluded, and 1 patient withdrew consent. Ninety-eight of 103 patients (95%) underwent resection. Four patients did not undergo surgery for either disease progression or patient refusal, and 1 patient died during induction chemotherapy. The median time of follow-up was 6.4 years in Arm 1 and 7.0 years in Arm 2. The pathological complete response (pCR) rates were 30% in Arm 1 and 26% in Arm 2. Locoregional recurrence rates were 16% in Arm 1 and 17% in Arm 2. Five-year survival rates were 61% and 75% and Disease-specific survival rates were 78% and 85% for Arm1 and Arm 2, respectively. Five second primaries occurred in patients on Arm 1, and 1 second primary occurred in Arm 2. CONCLUSIONS: High rates of disease-specific survival were seen in each arm. Overall survival appears affected by the development of unrelated second cancers. The high pCR rates with 5-FU and higher dose radiation in T4 cancers provide opportunity for increased R0 resections and improved survival.

Duke Scholars

Published In

Int J Radiat Oncol Biol Phys

DOI

EISSN

1879-355X

Publication Date

July 1, 2013

Volume

86

Issue

3

Start / End Page

523 / 528

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Failure
  • Survival Rate
  • Rectal Neoplasms
  • Radiotherapy Dosage
  • Oncology & Carcinogenesis
  • Neoadjuvant Therapy
  • Middle Aged
  • Male
  • Irinotecan
 

Citation

APA
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ICMJE
MLA
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Mohiuddin, M., Paulus, R., Mitchell, E., Hanna, N., Yuen, A., Nichols, R., … Willett, C. (2013). Neoadjuvant chemoradiation for distal rectal cancer: 5-year updated results of a randomized phase 2 study of neoadjuvant combined modality chemoradiation for distal rectal cancer. Int J Radiat Oncol Biol Phys, 86(3), 523–528. https://doi.org/10.1016/j.ijrobp.2013.02.020
Mohiuddin, Mohammed, Rebecca Paulus, Edith Mitchell, Nader Hanna, Albert Yuen, Romaine Nichols, Salochna Yalavarthi, Cherie Hayostek, and Christopher Willett. “Neoadjuvant chemoradiation for distal rectal cancer: 5-year updated results of a randomized phase 2 study of neoadjuvant combined modality chemoradiation for distal rectal cancer.Int J Radiat Oncol Biol Phys 86, no. 3 (July 1, 2013): 523–28. https://doi.org/10.1016/j.ijrobp.2013.02.020.
Mohiuddin M, Paulus R, Mitchell E, Hanna N, Yuen A, Nichols R, et al. Neoadjuvant chemoradiation for distal rectal cancer: 5-year updated results of a randomized phase 2 study of neoadjuvant combined modality chemoradiation for distal rectal cancer. Int J Radiat Oncol Biol Phys. 2013 Jul 1;86(3):523–8.
Mohiuddin, Mohammed, et al. “Neoadjuvant chemoradiation for distal rectal cancer: 5-year updated results of a randomized phase 2 study of neoadjuvant combined modality chemoradiation for distal rectal cancer.Int J Radiat Oncol Biol Phys, vol. 86, no. 3, July 2013, pp. 523–28. Pubmed, doi:10.1016/j.ijrobp.2013.02.020.
Mohiuddin M, Paulus R, Mitchell E, Hanna N, Yuen A, Nichols R, Yalavarthi S, Hayostek C, Willett C. Neoadjuvant chemoradiation for distal rectal cancer: 5-year updated results of a randomized phase 2 study of neoadjuvant combined modality chemoradiation for distal rectal cancer. Int J Radiat Oncol Biol Phys. 2013 Jul 1;86(3):523–528.
Journal cover image

Published In

Int J Radiat Oncol Biol Phys

DOI

EISSN

1879-355X

Publication Date

July 1, 2013

Volume

86

Issue

3

Start / End Page

523 / 528

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Failure
  • Survival Rate
  • Rectal Neoplasms
  • Radiotherapy Dosage
  • Oncology & Carcinogenesis
  • Neoadjuvant Therapy
  • Middle Aged
  • Male
  • Irinotecan