Garcia-Aguilar J, Shi Q, Thomas CR, Jr, et al. 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: 3.93). 07/2011; 19(2):384-91. DOI: 10.1245/s10434-011-1933-7
Source: PubMed


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.

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    • "A few prospective phase II trials of preoperative CRT and LE are ongoing. The American College of Surgeons Oncology Group (ACOSOG) trial Z6041 recently published preliminary results of preoperative CRT and LE for cT2N0 rectal cancer [8]. In addition, the Capecitabine, Radiotherapy and Transanal Endoscopic Microsurgery Surgery (CARTS) study, which will investigate the feasibility of preoperative CRT followed by transanal endoscopic microsurgery in patients with cT1-3N0 rectal cancer, is currently recruiting participants [9]. "
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    ABSTRACT: Purpose To evaluate the treatment outcomes of local excision following preoperative chemoradiotherapy in patients with locally advanced rectal cancer who have not undergone radical surgery for any reason. Materials and Methods The data of 27 patients with locally advanced rectal cancer who underwent preoperative chemoradiotherapy followed by local excision were analyzed retrospectively. The primary endpoint was the 5-year relapse-free survival rate, and the secondary endpoint was the pattern of recurrence. Results The median follow-up time was 81.8 months (range, 28.6 to 138.5 months). The 5-year local relapse-free survival (LRFS), distant metastasis-free survival (DMFS), relapse-free survival (RFS), and overall survival (OS) were 88.9%, 81.1%, 77.8%, and 85.0%, respectively. Six (22%) patients developed treatment failure; one (4%) patient had local recurrence only, three (11%) patients had distant recurrence only, and two (7%) patients had both. The 5-year LRFS, DMFS, RFS, and OS for patients with ypT0-1 compared with ypT2-3 were 94.1% vs. 77.8% (p=0.244), 94.1% vs. 55.6% (p=0.016), 88.2% vs. 55.6% (p=0.051), and 94.1% vs. 66.7% (p=0.073), respectively. Conclusion Local excision following preoperative chemoradiotherapy may be an alternative treatment for highly selected patients with locally advanced rectal cancer who have achieved ypT0-1 after preoperative chemoradiotherapy.
    Full-text · Article · Apr 2014 · Cancer Research and Treatment
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    • "Capecitabine and radiation doses were both reduced due to toxicity, but pCR rate (44%) and downstaging rate (64%) was high. 39% of patients developed CRT-related grade !3 complications with rectal pain the most common [85]. Finally, patient choice is of paramount importance when considering each step of the patient's intervention . "
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    ABSTRACT: Transanal endoscopic microsurgery (TEMS) is a well established method of accurate resection of specimens from the rectum under binocular vision. This review examines its role in the treatment of benign conditions of the rectum and the evidence to support its use and compliment existing endoscopic treatments. The evolution of TEMS in early rectal cancer and the concepts and outcomes of how it has been utilised to treat patients so far are presented. The bespoke nature of early rectal cancer treatment is changing the standard algorithms of rectal cancer care. The future of TEMS in the organ preserving treatment of early rectal cancer is discussed and how as clinicians we are able to select the correct patients for neoadjuvant or radical treatments accurately. The role of radiotherapy and outcomes from combination treatment using TEMS are presented with suggestions for areas of future research.
    Full-text · Article · Feb 2014 · Best practice & research. Clinical gastroenterology
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    • "Recently, Garcia-Aguilar et al. reported the preliminary results of the American College of Surgeons Oncology Group (ACOSOG) Z6041 trial [68], looking at short-term outcomes of neoadjuvant chemoradiation followed by local excision—performed by conventional transanal technique or TEM—for treatment of 77 patients with a clinically staged T2 N0 rectal cancer [68]. A complete pathological response was achieved in 34 patients (44%), while down-staging was observed in 49 patients (64%). "
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    ABSTRACT: Thanks to major advances in the field of surgical techniques and neoadjuvant chemoradiation therapy, along with more accurate pre-operative staging tools and the widespread introduction of population-based screening programs, treatment of rectal cancer has been evolving over the past few decades, moving towards a more tailored approach. This has brought a shift in the treatment algorithm of benign rectal lesions and selected early rectal cancers, for which today transanal endoscopic microsurgery (TEM) is accepted as an effective alternative to abdominal surgery. In 2013, topics of controversy are the role of TEM in the treatment of more advanced rectal cancers, in cases of complete pathological response after chemoradiation therapy and the role of TEM as a platform for single-port surgery and NOTES. This article reviews the current indications for TEM and the future perspectives of this approach in the treatment of rectal tumors.
    Full-text · Article · Sep 2013
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