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Poster lunch

1129 - Safety and antitumor activity of arsenic trioxide (ATO) plus infusional 5-FU, leucovorin and irinotecan (FOLFIRI) as second-line treatment for refractory metastatic colorectal cancer: Preliminary results from a pilot study (150P)


18 Nov 2017


Poster lunch


Cytotoxic Therapy;  Colon and Rectal Cancer


Tamojit Chaudhuri


Annals of Oncology (2017) 28 (suppl_10): x42-x56. 10.1093/annonc/mdx659


T. Chaudhuri, K.C. Lakshmaiah, K.G. Babu, L. Dasappa, L.A. Jacob, M.C.S. Babu, A.H. Rudresha, K.N. Lokesh, L.K. Rajeev

Author affiliations

  • Medical Oncology, Kidwai Memorial Institute of Oncology, 560029 - Bangalore/IN


Abstract 1129


After failing oxaliplatin-based first-line chemotherapy (CT), about 4-21% of patients with metastatic colorectal cancer (mCRC) respond to irinotecan-based second-line treatment. Prolonged exposure of colon cancer cells to 5-FU induces resistance, due to increased synthesis of thymidylate synthase (TS). Earlier studies have demonstrated that ATO can significantly re-sensitize resistant colon cancer cells to 5-FU by down regulating TS. Moreover, ATO can also act as a vascular disrupting agent and has synergistic effect with irinotecan on tumor growth delay. We hypothesized that a combination of ATO with FOLFIRI regimen in mCRC patients refractory to first-line FOLFOX, could further improve the outcome of second-line CT.


The inclusion criteria were: age ≥18 years; pathologically proven mCRC; ECOG PS ≤ 2; refractory to first-line FOLFOX; not affording for biologic agents due to economic constraint; adequate organ functions and measurable disease according to RECIST 1.1. Major exclusion criteria were: ≥2 lines of previous CT for metastatic disease; congestive cardiac failure and evidence of brain metastases. Patients were administered ATO 0.15 mg/kg/day on days 1 to 2, along with FOLFIRI regimen at standard doses every 2 weeks, until disease progression, unacceptable toxicity or patients’ refusal. Responses to CT were reported according to RECIST 1.1. Adverse events were classified based on CTCAE v 4.0.


Between October 2016 and May 2017, 13 patients with refractory mCRC were treated with this investigational combination. The median age was 47 years (range, 32-65); 10 males and 3 females; ECOG PS 0-1/2, 12/1; site of primary tumor rectum/colon, 8/5. Median baseline serum CEA was 78 ng/ml (range, 18-836). The most common site of metastases was liver (n = 7) followed by peritoneum (n = 5), lungs (n = 3) and non-regional lymph-nodes (n = 3); number of involved metastatic sites 1-2/≥3, 8/5. After 6 cycles of CT, overall response rate and disease control rate was 15.4% and 84.6% respectively (CR = 0, PR = 2 pts, SD = 9 pts); approximately 69% of patients experienced a ≥ 50% decline in serum CEA level. At a median follow-up of 5.5 months (range, 4-8), 7 patients had disease progression and kept on best supportive care; 6 patients were still on study drugs; and all 13 patients were alive. Median progression-free survival was 4.5 months (95%CI 3.8-5.2), from the initiation of ATO plus FOLFIRI. The toxicities were as follows: Grade 1/2 toxicity: fatigue (4 pts.), constipation (1), nausea and vomiting (1). Grade 3 toxicity: fatigue (3), neutropenia (2), diarrhea (2), QTc prolongation (1). No patient experienced grade 4 toxicities.


The addition of ATO 0.15 mg/kg/day on days 1 to 2, to standard FOLFIRI regimen as second-line CT in patients with refractory mCRC offers an encouraging anti-tumor effect at the cost of manageable toxicity.

Clinical trial identification

Not applicable

Legal entity responsible for the study

Kidwai Memorial Institute of Oncology, Bengaluru, Karnataka, India


Kidwai Memorial Institute of Oncology, Bengaluru, Karnataka, India


All authors have declared no conflicts of interest.

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