Adjuvant Chemotherapy for Locally Advanced Rectal Cancer: Is It a Given?

Abstract Objective This multicenter, single-arm phase II study (UMIN000008429) aimed to evaluate the efficacy and safety of capecitabine plus oxaliplatin (CapOX) as postoperative adjuvant chemotherapy for patients with locally advanced rectal cancer. Methods Patients with resectable clinical Stage II or III rectal cancer were enrolled to receive eight cycles of CapOX therapy (130 mg/m2 oxaliplatin on day 1 and 2000 mg/m2 oral capecitabine on days 1–14, every 3 weeks) after curative surgical resection. The primary endpoint was 3-year relapse-free survival (RFS) rate, and secondary endpoints were 3-year overall survival (OS) rate, treatment compliance, and safety. Results A total of 40 patients (Stage II, 21; Stage III, 19) were enrolled between September 2012 and November 2015 from seven institutions. Thirty-nine patients (97%) received R0 resection, and 32 patients (84%) received postoperative CapOX therapy. The completion rate of all eight cycles of CapOX therapy was 66%. Relative dose intensities were 87% for oxaliplatin and 84% for capecitabine. At a median follow-up period of 46 months, disease recurrence was observed in nine patients, including three with local recurrence. Three-year RFS and OS rates were 75% (95% CI 57–86%) and 96% (95% CI 80–99%), respectively. Frequencies of Grade ≥ 3 hematological and non-hematologic adverse events were 19% and 38%, respectively. Conclusion CapOX therapy is feasible as adjuvant chemotherapy for locally advanced rectal cancer.

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What determines adjuvant chemotherapy use after neoadjuvant chemoradiotherapy for rectal cancer?

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.4_suppl.546 ◽

2012 ◽

Vol 30 (4_suppl) ◽

pp. 546-546 ◽

Cited By ~ 1

Author(s):

George J. Chang ◽

Chung-Yuan Hu ◽

Y. Nancy You ◽

Cathy Eng ◽

Miguel A. Rodriguez-Bigas ◽

...

Keyword(s):

Rectal Cancer ◽

Adjuvant Chemotherapy ◽

Treatment Guidelines ◽

Locally Advanced ◽

Neoadjuvant Chemoradiotherapy ◽

Radical Resection ◽

Advanced Rectal Cancer ◽

Locally Advanced Rectal Cancer ◽

Clinicopathologic Characteristics ◽

Treatment Standard

546 Background: The treatment standard for rectal cancer patients after neoadjuvant chemoradiotherapy (CXRT) and radical resection includes adjuvant chemotherapy (CT). The purpose of this study was to evaluate patient demographic and clinicopathologic characteristics in relation to adjuvant CT use. Methods: A retrospective cohort study of patients ≥ 65 years old with rectal cancer treated by neoadjuvant CXRT and radical resection in the Surveillance, Epidemiology, and End Results-linked Medicare database (1998-2007, Medicare Part A/B only) was performed. Multivariate logistic regression was used to assess CT utilization in relation to patient, tumor and treatment response characteristics. Results: Among 1344 patients who met study criteria, 748 (55.6%) received adjuvant CT with 5-fluorouracil (FU) including 189 (25.3%) who also received oxaliplatin (Ox). ypStage was the strongest determinant of both any post-operative CT (43.1% stage I, 51.3% stage II, 73.4% stage III). Other associated factors included age, comorbidity, marital status and surgery type. In addition, age, socioeconomic status, and grade were associated with Ox use. These effects persisted even after exclusion of patients with comorbidities. Conclusions: Although standard treatment guidelines for locally advanced rectal cancer include postoperative CT for all patients after neoadjuvant CXRT and radical resection, nearly 1 in 2 patients failed to receive adjuvant CT. Despite the absence of established evidence, treatment decisions appear to be influenced by the findings at surgical pathology. [Table: see text]

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Induction chemotherapy followed by chemoradiotherapy and total mesenteric excision for locally advanced rectal cancer with resectable metastases.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.4_suppl.526 ◽

2013 ◽

Vol 31 (4_suppl) ◽

pp. 526-526 ◽

Cited By ~ 1

Author(s):

Carla Hajj ◽

Andrea Cercek ◽

Leonard Saltz ◽

Neil Howard Segal ◽

Diane Lauren Reidy ◽

...

Keyword(s):

Rectal Cancer ◽

Overall Survival ◽

Adjuvant Chemotherapy ◽

Induction Chemotherapy ◽

Primary Tumor ◽

Tumor Regression ◽

Locally Advanced ◽

Pathologic Complete Response ◽

Advanced Rectal Cancer ◽

Locally Advanced Rectal Cancer

526 Background: Optimal management of patients with locally advanced rectal cancer (LARC) and synchronous, resectable metastases remains controversial and treatment decisions benefit from a multidisciplinary approach. To better characterize the role of induction chemotherapy followed by chemoradiation and surgery, we evaluated patterns of distal progression and overall survival in this subset of patients. Methods: We reviewed records of 25 LARC patients with synchronous resectable metastases treated with induction chemotherapy (ICT) followed by 5-fluorouracil-based concurrent chemoradiation (CRT) at our institution between December 2006 and December 2010. Radiation was delivered using a standardized three-field technique or IMRT. The incidence and sites of failure were analyzed. Overall survival (OS) and progression-free survival (PFS) were calculated from the completion of CRT using the Kaplan-Meier method. Results: Of the 25 patients who received ICT followed by CRT, 21 (84%) underwent total mesorectal excision and metastectomy. Eleven patients (44%) had liver metastases. The median ICT duration was 2.4 months. Twenty patients (80%) received a FOLFOX-based ICT regimen and 5 patients (20%) received irinotecan-based chemotherapy. Two patients had unresectable disease, one was medically inoperable, and surgery was aborted due to intra-operative complications in one patient. Eighteen of the 21 were NED after surgery and metastatectomy (86%) with 24% pathologic complete response rate in the primary tumor; 10 (56%) received adjuvant chemotherapy. None of the patients recurred locally. Six of the 18 (33%) progressed distally, four of whom had received adjuvant chemotherapy. Four distal recurrences were in the lungs. With a median follow-up of 29.6 months, the 3-year OS was 50.4%. Median OS and PFS were 25.1 months and 13.5 months, respectively. Conclusions: ICT prior to CRT is associated with acceptable toxicity, substantial primary tumor regression, and promising clinical outcomes in patients with high-risk LARC with synchronous, resectable metastatic disease.

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Results of European pooled analysis of IORT-containing multimodality treatment for locally advanced rectal cancer: adjuvant chemotherapy prevents local recurrence rather than distant metastases

Annals of Oncology ◽

10.1093/annonc/mdp501 ◽

2010 ◽

Vol 21 (6) ◽

pp. 1279-1284 ◽

Cited By ~ 65

Author(s):

M. Kusters ◽

V. Valentini ◽

F.A. Calvo ◽

R. Krempien ◽

G.A. Nieuwenhuijzen ◽

...

Keyword(s):

Rectal Cancer ◽

Adjuvant Chemotherapy ◽

Local Recurrence ◽

Locally Advanced ◽

Multimodality Treatment ◽

Distant Metastases ◽

Advanced Rectal Cancer ◽

Locally Advanced Rectal Cancer ◽

Pooled Analysis

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Systematic Review: Adjuvant Chemotherapy for Locally Advanced Rectal Cancer with respect to Stage of Disease

International Scholarly Research Notices ◽

10.1155/2015/710569 ◽

2015 ◽

Vol 2015 ◽

pp. 1-10

Author(s):

Shahab Hajibandeh ◽

Shahin Hajibandeh

Keyword(s):

Rectal Cancer ◽

Adjuvant Chemotherapy ◽

Locally Advanced ◽

Disease Free Survival ◽

Advanced Rectal Cancer ◽

Locally Advanced Rectal Cancer ◽

Stage Ii ◽

Stage Iii ◽

Free Survival ◽

Disease Free

Background. Recent meta-analysis of 21 randomised controlled trials (RCTs) supports the use of adjuvant chemotherapy for nonmetastatic rectal carcinoma. In order to define a subgroup of patients who can potentially benefit from postoperative adjuvant chemotherapy, this study aims to review trials investigating adjuvant chemotherapy with respect to stage of disease in patients with locally advanced rectal cancer who had undergone surgery for cure (stage II and stage III). Methods. We searched electronic information sources to identify randomised trials evaluating adjuvant chemotherapy in patients with stages II and III rectal cancer with overall survival or disease-free survival as outcomes. Scottish Intercollegiate Guidelines Network notes on methodology were used to assess the methodological quality of the selected studies. Random-effects models were applied to calculate pooled outcome data. Results. Eight studies reporting total of 5527 patients were selected for analysis. Adjuvant chemotherapy was associated with statistically significant improvement in disease-free survival and overall survival compared to surgery alone in both stage II and stage III cancer. Conclusions. This study indicates that both stage II and stage III rectal cancer patients may benefit from postoperative adjuvant chemotherapy. However, the benefits of adjuvant chemotherapy for patients who already had neoadjuvant chemoradiation still remain unknown.

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