Evaluation of FOLFOX or CAPOX reintroduction with or without bevacizumab in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy (REACT study).

BACKGROUND: Chemotherapy in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy is under debate. REACT study aimed to investigate the efficacy of reintroducing modified FOLFOX6 (mFOLFOX6) or CAPOX with or without bevacizumab in recurrent colorectal cancer patients after oxaliplatin adjuvant chemotherapy. METHODS: Patients that participated in this trial had a medical history of adjuvant chemotherapy, including oxaliplatin with a cumulative dose greater than 400 mg/m2, and recurrence that was diagnosed more six months post adjuvant chemotherapy. Primary endpoints were response rate (RR) and disease control rate (DCR), while key secondary endpoints were time to treatment failure (TTF), progression-free survival (PFS), overall survival (OS), and safety. RESULTS: A total of 31 patients were enrolled between October 2012 and October 2016. Of the 29 eligible patients, 7 received mFOLFOX6 and 22 received CAPOX. The RR was 62.1% (95% confidence interval 42.3-79.3) and the DCR was 82.8% (95% confidence interval 64.2-94.2). The RR for oxaliplatin-free interval was 100.0% in months 6-12 and 56.0% after 12 months. Median TTF, PFS, and OS were 6.3, 10.8, and 28.7 months, respectively. Grade 3 or worse peripheral sensory neuropathy developed in 6.5%. Allergic reactions occurred in 12.9% of the patients, with one (3.2%) grade 3 episode. There were no other severe treatment-related adverse events. CONCLUSION: Reintroduction of oxaliplatin was feasible and achieved high RR or DCR in patients after more than 6 months post oxaliplatin adjuvant chemotherapy.

Interim analysis of a phase II trial evaluating the safety and efficacy of capecitabine plus oxaliplatin (XELOX) as adjuvant therapy in Japanese patients with operated stage III colon cancer.

PURPOSE: Adjuvant oxaliplatin plus oral capecitabine (XELOX) is recommended for patients with curatively resected colon cancer. However, its safety and tolerability in Asian patients is unclear; therefore, we evaluated the safety and efficacy of adjuvant XELOX in Japanese patients with curatively resected stage III colon cancer (MCSCO-1024) and present the interim safety data. METHODS: This prospective, multi-center, open-label, single-arm phase II study recruited patients with curatively resected stage III colon cancer. The protocol was a 120-min intravenous infusion of oxaliplatin (130 mg/m2) on day 1 and oral capecitabine (2000 mg/m2/day) in two divided doses for 14 days of a 3-week cycle, for a total of eight cycles (24 weeks). The primary endpoint was the 3-year disease-free survival, and secondary endpoints were the treatment completion rate, safety profile (rate and severity of adverse events), and correlation of adverse events, such as peripheral sensory neuropathy (PSN), with the administration period of oxaliplatin, etc. RESULTS: From November 2011 to August 2014 (34 months), 196 patients were enrolled. Safety was analyzed in 190 patients. The median total doses of capecitabine and oxaliplatin were 215,586.9 and 777.2 mg/m2, respectively, while the median relative dose intensities were 82.5 and 76.0%, respectively. The overall treatment completion rate was 73.7%. The most frequent treatment-related adverse event was PSN (88.4%), while the most frequent grade ≥3 treatment-related adverse events were neutropenia (12.6%), PSN (6.3%), diarrhea (4.2%), and thrombocytopenia (4.2%). There were no treatment-related deaths. CONCLUSIONS: Adjuvant XELOX is tolerable for Japanese patients with Stage III colon cancer.

[Preoperative chemoradiation (XELOX/RT) therapy for anal canal adenocarcinoma with the metastasis to inguinal lymph node].

For a woman with poorly-differentiated anal canal adenocarcinoma in acknowledgment of metastasis to right inguinal lymph node, we gave radiotherapy combined with capecitabine as chemotherapy. Then the next two months, we performed XELOX therapy. Subsequently, we performed laparoscopic rectal amputation+D1 dissection+right groin lymph node dissection. The effect of preoperative chemoradiotherapy and pathological examination of the main tumor was Grade 2. And the right inguinal lymph node showed only a mucous persistence. Capecitabine was given as an adjuvant postoperative treatment and did not show a recurrence for five months after the operation. For a treatment for anal canal adenocarcinoma in acknowledgment of metastasis to inguinal lymph node, preoperative chemoradiotherapy may be effective.

[Idiopathic thrombocytopenic purpura during chemotherapy for liver metastasis of rectal cancer].

UNLABELLED: Neoadjuavnt chemotherapy for liver metastasis of colorectal cancer implies issues about timing for resection and management for adverse events due to chemotherapy. CASE: A 50-year-old male patient with synchronous liver metastasis from rectal cancer had a surgery for primary lesion followed by neo-adjuvant chemotherapy for liver resection. Chemotherapy of bevacizumab + mFOLFOX6 achieved a partial response for liver metastasis. When we planned a liver resection, platelet count decreased to 1.4 × 10(4)/µL. The patient was diagnosed as idiopathic thrombocytopenic purpura (ITP) by several examinations but medical control including steroids failed. Partial splenic artery embolization could recover platelet count successfully. However, during the period of therapy for ITP, liver metastasis became unresectable. The patient is currently treated by FOLFIRI and with stable disease for three months. CONCLUSION: NeoPyloriadjuvant chemotherapy for respectable liver metastasis should be considered carefully in terms of timing for resection and prompt management for adverse events.

[A case of multiple liver metastases from rectal cancer in poor performance status successfully treated with hepatic arterial infusion chemotherapy plus CPT-11].

Hepatic arterial infusion (HAI) chemotherapy is one of the strategies for cases in poor performance status. This is a case report of multiple liver metastases from rectal cancer in poor performance status successfully treated with HAI plus CPT-11. A 59-year-old man who had rectal cancer, multiple liver metastases and para-aortic LN metastasis underwent a laparoscopic rectal anterior resection. He denied receiving postoperative chemotherapy and selected alternative therapy at another clinic. Four months later, he visited our hospital. His liver metastasis and performance status got worse, so HAI of 5-FU 1250 mg/m2 for 5-hour weekly (weekly high-dose 5-FU: WHF) was started at first. After 3 courses, his status improved, so systemic chemotherapy was added. HAI (WHF: 1000 mg/m2) plus CPT-11 (100 mg/m2) was effective, and liver metastases showed a significant reduction (PR) on abdominal CT. HAI plus CPT-11 was effective for a patient of the poor performance status with unresectable liver metastasis.