Impact of Adjuvant Chemotherapy in Patients With Curatively Resected Stage IV Colorectal Cancer

638 Background: In previous phase III studies (MOSAIC and XELOXA trial), oxaliplatin based chemotherapy was shown to be a standard adjuvant treatment for stage III colorectal cancer (CRC). However, its efficacy for curatively resected stage IV CRC has not yet been clarified. In this retrospective study, we evaluate the efficacy of oxaliplatin based chemotherapy in adjuvant setting for curatively resected stage IV CRC. Methods: Eighty-three patients received adjuvant chemotherapy after R0 resection for Stage IV CRC in our institute between Mar 2007 and Feb 2013. Progression-free survival (PFS), overall survival (OS), completion rate of the treatment and safety were evaluated. Median follow-up time was 33.3 months. Results: Baseline characteristics were as follows (N=83): median age, 61; male/female, 46/37; ECOG PS0, all; colon/rectum, 54/29; synchronous/asynchronous, 41/42. Metastatic sites were liver in 46, lung in 11, peritoneum in 13, lymph node in 12 patients. Median PFS and OS were not reached. Three-year PFS and OS were 67.8% and 88.2%, respectively. Completion rate was 78.6% of the patients. In univariate analysis, completion of treatment, synchronous development and metastasis limited to lung were associated with better PFS, though not statistically significant. Confirmed regional lymph node metastasis of primary tumor showed a trend toward to concern with poor OS. Differences in metastatic site were not observed in both PFS and OS. Multivariate analysis revealed none as a significant prognostic factor. Conclusions: Compared the results to previous trial for stage III CRC, oxaliplatin based adjuvant chemotherapy for stage IV CRC after R0 resection was demonstrated to be consistent in tolerability and efficacy.

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Capecitabine maintenance therapy after adjuvant chemotherapy of FOLFOX (or XELOX) in patients with stage IIIC or R0 resected stage IV colorectal cancer (CAMCO study).

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.4_suppl.tps781 ◽

2016 ◽

Vol 34 (4_suppl) ◽

pp. TPS781-TPS781

Author(s):

Jiayu Ling ◽

Wenjing Wang ◽

Shanshan Li ◽

Yue Cai ◽

Huabin Hu ◽

...

Keyword(s):

Colorectal Cancer ◽

Clinical Trial ◽

High Risk ◽

Adjuvant Chemotherapy ◽

Adjuvant Therapy ◽

Maintenance Therapy ◽

Stage Iv ◽

Stage Iiic ◽

Resected Stage ◽

Clinical Trial Information

TPS781 Background: Surgical resection and adjuvant therapy has become the main treatment for resectable colorectal cancer (CRC). Treatment with current strategies, however, recurrent rate is high for stage IIIc or R0 resected stage IV CRC (high risk-CRC). For some other maglinancies with high risk of recurrence, such as gastric cancer or high-risk gastrointestinal stromal tumor, longer period of postoperative chemotherapy was applied. The effectiveness of maintenance therapy following standard adjuvant chemotherapy in high risk-CRC has not been verified in clinical trial. Capecitabine is is an orally-administered chemotherapeutic agent used in the treatment of CRC, either as neoadjuvant therapy with radiation, adjuvant therapy or for metastatic cases. This study is exploring the efficacy and safety of strategy of surgical resection and adjuvant chemotherapy followed by maintenance capecitabine for stage IIIC or R0 resected stage IV CRC. Methods: The study was designed as an open-label phase II trial with 200 patients assigned to two thearapy group: experimental arm A (Adjuvant chemotherapy with mFOLFOX6 or XELOX for more than four months + oral capecitabine 1000mg/m2 twice daily days1-14 every 3 weeks for 12 months maintenance) or standard arm B (Adjuvant chemotherapy with mFOLFOX6 or XELOX for more than four months + observation). Eligibility included patients of 18-80 years of age, diagnosis of adenocarcinoma of the colon or rectum, received curative resection when diagnosed, with postoperative stage of IIIC OR IV(R0 resected), PS 0-1 and adequate organ function. Doses were modified for hand-foot syndrome, diarrhea and other grade 3 toxicities. The primary aim is to evaluate the 3 year disease free survival of the patients. Secondary aims inclued overall survival, safety, quality of life and an assessment of predictive molecular markers of maintenance strategy. After completion of adjuvant treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3rd-5th years. This study is now open to accrual in The Sixth Affiliated Hospital of Sun Yat-sen University. Clinical trial information: NCT01880658. Clinical trial information: NCT01880658.

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