scholarly journals Factors predicting the response to oral fluoropyrimidine drugs: A phase II trial on the individualization of postoperative adjuvant chemotherapy using oral fluorinated pyrimidines in stage III colorectal cancer treated by curative resection (ACT-01 Study)

2012 ◽  
Vol 29 (2) ◽  
pp. 437-444 ◽  
Author(s):  
TAKEO MORI ◽  
MASAYUKI OHUE ◽  
YASUMASA TAKII ◽  
TADASHI HASHIZUME ◽  
TOMOYUKI KATO ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Curative Resection ◽  
Phase Ii Trial ◽  
Stage Iii ◽  
Postoperative Adjuvant Chemotherapy ◽  
Oral Fluoropyrimidine ◽  
Fluorinated Pyrimidines

scholarly journals Efficacy of aspirin for stage III colorectal cancer: a randomized double-blind placebo-controlled trial (JCOG1503C, EPISODE-III trial)

2019 ◽  
Vol 49 (10) ◽  
pp. 985-990 ◽  
Author(s):  
Kenichi Miyamoto ◽  
Atsuo Takashima ◽  
Junki Mizusawa ◽  
Yuya Sato ◽  
Yasuhiro Shimada ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Adverse Events ◽  
Curative Resection ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Stage Iii ◽  
Double Blind ◽  
Free Survival ◽  
Double Blind Placebo

Abstract Adjuvant chemotherapy is the current standard treatment for stage III colorectal cancer after curative resection. However, the prognosis of stage III colorectal cancer is still poor even after curative resection and adjuvant chemotherapy. Several observational studies suggested that the anti-tumor effect of aspirin. Therefore, we planned a randomized double-blind placebo-controlled phase III trial, which commenced in Japan in March 2018, to confirm the superiority of aspirin over placebo added to adjuvant chemotherapy in terms of disease-free survival (DFS) for stage III colorectal cancer patients after curative resection. A total of 880 patients will be accrued from 20 Japanese institutions within 3 years. The primary endpoint is DFS and the secondary endpoints are overall survival, relapse-free survival, relative dose intensity, adverse events, and serious adverse events. This trial has been registered at Japan Registry of Clinical Trials as jRCTs031180009 (https://jrct.niph.go.jp/detail/589).

Efficacy of aspirin for stage III colorectal cancer: A randomized double-blind placebo-controlled trial (JCOG1503C, EPISODE-III trial).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS3623-TPS3623
Author(s):  
Atsuo Takashima ◽  
Kenichi Miyamoto ◽  
Yuya Sato ◽  
Natsuko Okita ◽  
Manabu Shiozawa ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adjuvant Chemotherapy ◽  
Adverse Events ◽  
Curative Resection ◽  
Phase Iii ◽  
Stage Iii ◽  
Double Blind ◽  
Free Survival ◽  
Double Blind Placebo ◽  
Aspirin Group

TPS3623 Background: Adjuvant chemotherapy is the current standard treatment for stage III colorectal cancer after curative resection. However, the prognosis of stage III colorectal cancer is still poor even after curative resection and adjuvant chemotherapy. Recently, several observational studies suggested the anti-tumor effect of aspirin for advanced colorectal cancer. The main mechanism of the anti-tumor effect by aspirin may be to suppress cyclooxygenase activity in the arachidonic acid cascade and to inhibit the production of prostaglandins involved in tumor growth. So far, aspirin showed a prolongation of survival for colorectal cancer in several retrospective studies. However, in these studies, aspirin was given not to be evaluated the effect on prognosis of colorectal cancer in adjuvant setting but to prevent cardiovascular event. In addition, baseline patient characteristics were imbalanced between aspirin group and non-aspirin group and both dosage amount and dosing period of aspirin were different among patients. Methods: We planned a randomized double-blind placebo-controlled phase III trial commenced in Japan in March 2018 to confirm the superiority of aspirin in terms of disease-free survival (DFS) over placebo for stage III colorectal cancer patients after curative resection. Patients receive aspirin (100 mg/day) or placebo for 3 years with the standard adjuvant chemotherapy of mFOLFOX6, CAPOX or capecitabine until relapse or unacceptable toxicities. The primary endpoint is DFS and the secondary endpoints are overall survival, relapse-free survival, relative dose intensity, adverse events, and serious adverse events. We assumed the 3-year DFS of aspirin arm as 74% based on two previous trials conducted by JCOG and expected a 6% increase in the 3-year DFS with aspirin adding to standard adjuvant chemotherapy after curative surgery. A total of 880 patients will be accrued from 20 Japanese institutions within 3 years, and 47 patients were enrolled as of Jan 31, 2019. Both aspirin and placebo are provided by Bayer Yakuhin Ltd. This trial has been registered at Japan Registry of Clinical Trials as jRCTs031180009 (https://jrct.niph.go.jp/detail/589). Clinical trial information: jRCTs031180009.

scholarly journals A Phase II Clinical Study of mFOLFOX6 /XELOX as Adjuvant Chemotherapy after Curative Resection of Stage III Colon Cancer: The FACOS Study

2016 ◽  
Vol 24 (1) ◽  
pp. 17-22 ◽  
Author(s):  
Keiichiro Ishibashi ◽  
Kensuke Kumamoto ◽  
Keiji Koda ◽  
Hiroyuki Kato ◽  
Genichi Nishimura ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Clinical Study ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Curative Resection ◽  
Stage Iii ◽  
Stage Iii Colon Cancer ◽  
Phase Ii Clinical Study

scholarly journals Significance of postoperative adjuvant chemotherapy with an oxaliplatin-based regimen after simultaneous curative resection for colorectal cancer and synchronous colorectal liver metastasis: a propensity score matching analysis

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kiichi Sugimoto ◽  
Kazuhiro Sakamoto ◽  
Yuki Ii ◽  
Kota Amemiya ◽  
Hiroyuki Sugo ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Resection ◽  
Adjuvant Chemotherapy ◽  
Propensity Score ◽  
Curative Resection ◽  
Univariate Analysis ◽  
Maximum Diameter ◽  
Remnant Liver ◽  
Postoperative Adjuvant Chemotherapy ◽  
Simultaneous Resection

Abstract Background Expansion of the indication for liver resection and new regimens for systemic chemotherapy have improved postoperative outcomes for synchronous colorectal liver metastases (CRLM). However, such cases can still have a high recurrence rate, even after curative resection. Therefore, there is a need for postoperative adjuvant chemotherapy (POAC) after liver resection in patients with CRLM. There are few studies of the efficacy of POAC with an oxaliplatin-based regimen after simultaneous resection for colorectal cancer and CRLM with curative intent. The goal of the study was to compare POAC with oxaliplatin-based and fluoropyrimidine regimens using propensity score (PS) matching analysis. Methods The subjects were 94 patients who received POAC after simultaneous resection for colorectal cancer and synchronous CRLM, and were enrolled retrospectively. The patients were placed in a L-OHP (+) group (POAC with an oxaliplatin-based regimen, n = 47) and a L-OHP (−) group (POAC with a fluoropyrimidine regimen, n = 47). Recurrence-free (RFS), cancer-specific (CSS), unresectable recurrence-free (URRFS), remnant liver recurrence-free (RLRFS), and extrahepatic recurrence-free (EHRFS) survival were analyzed. Results Before PS matching, the L-OHP (+) and (−) groups had no significant differences in RFS, CSS, URRFS, RLRFS, and EHRFS. Univariate analysis indicated significant differences in age, preoperative serum CEA (≤ 30.0 ng/mL/ > 30.0 ng/mL), differentiation of primary tumor (differentiated/undifferentiated), T classification (T1–3/T4), number of hepatic lesions and maximum diameter of the hepatic lesion between the L-OHP (+) and (−) groups. After PS matching using these confounders, RFS was significantly better among patients in the L-OHP (+) group compared with the L-OHP (−) group (HR 0.40, 95% CI 0.17–0.96, p = 0.04). In addition, there was a trend towards better RLRFS among patients in the L-OHP (+) group compared with the L-OHP (−) group (HR 0.42, 95% CI 0.17–1.02, p = 0.055). However, there were no significant differences in CSS, URRFS and EHRFS between the L-OHP (+) and (−) groups. Conclusions PS matching analysis demonstrated the efficacy of POAC with an oxaliplatin-based regimen in RFS and RLRFS.

Survival results of hepatectomy followed by adjuvant chemotherapy with three months of capecitabine plus oxaliplatin for colorectal cancer liver metastases: A multicenter phase II study.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 866-866 ◽  
Author(s):  
Hironaga Satake ◽  
Hiroki Hashida ◽  
Hiroaki Tanioka ◽  
Yasuhiro Miyake ◽  
Shinichi Yoshioka ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Liver Metastases ◽  
Phase Ii ◽  
Curative Resection ◽  
Completion Rate ◽  
Colorectal Cancer Liver Metastases ◽  
Oral Capecitabine ◽  
Stage Iii Colon Cancer

866 Background: Hepatic resection is one of the treatment strategies for resectable colorectal cancer liver metastases (CLM). The role of neoadjuvant and adjuvant chemotherapy in the management of initially resectable CLM is still unclear. Adjuvant chemotherapy consisting of capecitabine plus oxaliplatin (CapeOx) appears to be equivalent to FOLFOX in patients with stage III colon cancer. Furthermore, the IDEA collaboration reported that adjuvant chemotherapy with the three months of CapeOx after curative resection for stage III colon cancer has equivalent efficacy to adjuvant chemotherapy for 6 months. We conducted a multi-institutional, single-arm, phase II trial to confirm the feasibility of the three months of adjuvant CapeOx for post curative resection of CLM. Methods: Patients received one course of capecitabine followed by four courses of CapeOx for a total five courses (15 weeks) as adjuvant chemotherapy after curative resection of CLM. Oral capecitabine was given with 1,000 mg/m2 twice daily for 2 weeks in a 3-week cycle, and CapeOx consisted of oral capecitabine plus oxaliplatin 130 mg/m2 on day 1 in a 3-week cycle. The primary endpoint was completion rate of adjuvant chemotherapy. We set a threshold completion rate of protocol treatment of 45% and an expected completion rate of 70%. Given a one-sided α of 0.1 and statistical power of 80%, a minimum of 25 patients was required. Results: From May 2013 to November 2015, Twenty-eight patients were enrolled from six institutions: median age 69.5y, 54% male, 78.5% left-sided primary. Of the patients, 15 were synchronous metastases and 13 were metachronous. The locations of the metastases were unilobar in 20 patients and bilobar in 8. The mean number of lesions resected was two (range, 1 to 4). Among the 28 patients, 20 (71.4%: 95% CI, 53.6 to 89.3%) completed the protocol treatment. The most common grade 3/4 toxicities were neutropenia (29%). No treatment related death was observed. With a median follow-up period of 36 months (range 15-53months), 3 year-relapse free survival was 75.3%. Conclusions: The three months of adjuvant CapeOx is tolerable for post curative resection of CLM. Clinical trial information: 000011164.

scholarly journals Severe rhabdomyolysis related to oxaliplatin adjuvant therapy for colorectal cancer

2019 ◽  
Vol 12 (4) ◽  
pp. e228673 ◽  
Author(s):  
Ana Pissarra ◽  
Mariana Malheiro ◽  
Leonor Vasconcelos Matos ◽  
Ana Neto Plácido
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Stage Iii ◽  
Standard Chemotherapy ◽  
Postoperative Adjuvant Chemotherapy ◽  
Stage Iii Colon Cancer ◽  
Distal Muscle ◽  
Common Cancer ◽  
Resected Stage

Colorectal cancer is the third most common cancer in men and the second in women. The standard chemotherapy regiment in stage III colon cancer is based in oxaliplatin. The most common side effects include neutropenia, peripheral neuropathy, vomiting and diarrhoea. Rhabdomyolysis due to oxaliplatin is rare, and there are no established guidelines for managing this adverse event. This report describes a case of a 52-year-old man, with a resected stage III colon cancer that started postoperative adjuvant chemotherapy with capecitabine plus oxaliplatin. After the second cycle, the patient developed distal muscle pain and weakness, with a total inability to walk. Blood tests showed an elevated creatine kinase and renal injury. Severe drug-related rhabdomyolysis was diagnosed. The goal of this case report is to discuss the side effect of adjuvant chemotherapy, given its rarity and severity.

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