Article

A Phase II Trial of Neoadjuvant Chemoradiation and Local Excision for T2N0 Rectal Cancer: Preliminary Results of the ACOSOG Z6041 Trial

Department of Surgery, City of Hope, Duarte, USA.
Annals of Surgical Oncology (Impact Factor: 3.94). 07/2011; 19(2):384-91. DOI: 10.1245/s10434-011-1933-7
Source: PubMed

ABSTRACT We designed American College of Surgeons Oncology Group (ACOSOG) Z6041, a prospective, multicenter, single-arm, phase II trial to assess the efficacy and safety of neoadjuvant chemoradiation (CRT) and local excision (LE) for T2N0 rectal cancer. Here, we report tumor response, CRT-related toxicity, and perioperative complications (PCs).
Clinically staged T2N0 rectal cancer patients were treated with capecitabine and oxaliplatin during radiation followed by LE. Because of toxicity, capecitabine and radiation doses were reduced. LE was performed 6 weeks after CRT. Patients were evaluated for clinical and pathologic response. CRT-related complications and PCs were recorded.
Ninety patients were accrued; 6 received nonprotocol treatment. The remaining 84 were 65% male; median age 63 years; 83% Eastern Cooperative Oncology Group performance score 0; 92% white; mean tumor size 2.9 cm; and average distance from anal verge 5.1 cm. Five patients were considered ineligible. Therapy was completed per protocol in 79 patients, but two patients did not undergo LE. Among 77 eligible patients who underwent LE, 34 patients achieved a pathologic complete response (44%) and 49 (64%) tumors were downstaged (ypT0-1), but 4 patients (5%) had ypT3 tumors. Five LE specimens contained lymph nodes; one T3 tumor had a positive node. All but one patient had negative margins. Thirty-three (39%) of 84 patients developed CRT-related grade ≥3 complications. Rectal pain was the most common PC.
CRT before LE for T2N0 tumors results in a high pathologic complete response rate and negative resection margins. However, complications during CRT and after LE are high. The true efficacy of this approach will ultimately be assessed by the long-term oncologic outcomes.

1 Bookmark
 · 
305 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: The optimal treatment of early (T1 and T2) rectal adenocarcinomas remains controversial. Local excision and radical resection with total mesorectal excision are the two surgical techniques for excising early rectal cancer. Each has their respective benefits, with local excision allowing for decreased operative morbidity and mortality while radical resection provides an oncologically complete treatment through lymphadenectomy. Local excision can be accomplished via transanal endoscopic microsurgery or transanal excision. There is no significant difference in the recurrence rates (21% vs. 33%) or overall survival (80% vs. 66%) between the two local excision modalities; however, transanal endoscopic microsurgery does allow for a higher rate of R0 resection. Current selection criteria for local excision include well to moderately differentiated tumors without high-risk features such as lymphovascular invasion, perineural invasion, or mucinous components. In addition, tumors should ideally be <3 cm in size, excised with a clear margin, occupy less than 1/3 of the circumference of the bowel and be mobile/nonfixed. Despite these stringent inclusion criteria, local excision continues to be plagued with a high recurrence rate in both T1 and T2 tumors due to a significant rate of occult locoregional metastases (20% to 33%). For both tumor groups, the recurrence rate in the local excision group is more than double compared to radical resection. However, the overall survival is not significantly different between those with and without metastases. With intense postoperative surveillance, these recurrences can be identified early while they are confined to the pelvis allowing for salvage surgical options. Recently, neoadjuvant therapy followed by local excision has shown favorable short and long-term oncological outcomes to radical resection in the treatment of T2 rectal cancer. Ultimately, the management of early rectal cancer must be individualized to each patient's expectations of quality and quantity of life. With informed consent, patients may be willing to accept a higher failure rate and an increased post-operative surveillance regimen to preserve a perceived increased quality of life.
    Journal of gastrointestinal oncology 10/2014; 5(5):345-352. DOI:10.3978/j.issn.2078-6891.2014.066
  • [Show abstract] [Hide abstract]
    ABSTRACT: Neoadjuvant chemoradiation (CRT) is considered one of the preferred treatment strategies for patients with locally advanced rectal cancer. This strategy may lead to significant tumor regression, ultimately leading to a complete pathologic response in up to 42% of patients. Assessment of tumor response following CRT and before radical surgery may identify patients with a complete clinical response who could possibly be managed nonoperatively with strict follow-up (watch-and-wait strategy). The present article deals with critical issues regarding appropriate selection of patients for this approach. Copyright © 2015 Elsevier Inc. All rights reserved.
  • [Show abstract] [Hide abstract]
    ABSTRACT: Sphincter preservation (SP) is an important goal of rectal cancer surgery. We hypothesized that SP rates among veteran patients have increased and are comparable to national rates, and that a subset of patients with early disease still undergo non-SP procedures.
    Annals of Surgical Oncology 09/2014; DOI:10.1245/s10434-014-4101-z · 3.94 Impact Factor

Full-text (2 Sources)

Download
136 Downloads
Available from
May 21, 2014