Hyaluronan-Irinotecan improves progression-free survival in 5-fluorouracil refractory patients with metastatic colorectal cancer: a randomized phase II trial |
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Authors: | Peter Gibbs Philip R Clingan Vinod Ganju Andrew H Strickland Shirley S Wong Niall C Tebbutt Craig R Underhill Richard M Fox Steven P Clavant Jenny Leung Minh Pho Tracey J Brown |
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Institution: | 1. Department of Medical Oncology and Haematology, Royal Melbourne Hospital, Parkville, Melbourne, Australia 2. Southern Medical Day Care, Department of Medical Oncology, University of New South Wales, St. George Hospital, Kogarah, NSW, Australia 3. Department of Oncology, Frankston Hospital, Frankston, VIC, Australia 4. Department of Oncology, Monash Medical Centre, 246 Clayton Road, Clayton, VIC, Australia 5. Department of Medical Oncology and Haematology, Western General Hospital, Footscray, VIC, Australia 6. Ludwig Oncology Unit, Austin Health, Heidelberg, VIC, Australia 7. Border Medical Oncology, Albury-Wodonga, NSW, Australia 8. Laboratory for Hyaluronan Research, Department of Biochemistry and Molecular Biology, Monash University, Wellington Road, Clayton, Melbourne, 3800, Australia 9. Alchemia Oncology Limited, 737 Burwood Rd, Hawthorn, VIC, Australia
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Abstract: | Purpose The objective of this study was to conduct a randomised phase II study in second-line metastatic colorectal cancer with the purpose of confirming preliminary clinical data indicating that the formulation of irinotecan with the drug carrier, hyaluronan (HA) reduced toxicity of the drug. Methods Irinotecan-na?ve patients were randomized to receive either irinotecan (350?mg/m2) or HA-Irinotecan (HA 1,000?mg/m2 and irinotecan at 350?mg/m2) every 3?weeks for a maximum of eight cycles. Results Seventy-six patients (41 HA-Irinotecan and 35 irinotecan-alone) were enrolled. There was no significant difference in any individual, or overall, grade 3 or 4 toxicity. There was a trend for increased diarrhea in the HA-Irinotecan-treated patients (20 versus 9%; P?=?21), potentially explained by a disproportionate number of baseline toxicity-associated risk factors in this treatment group. The median number of cycles completed was six for HA-Irinotecan patients and two for irinotecan-alone patients (P?=?0.005). When compared to the control arm, HA-Irinotecan patients had a significantly longer median progression-free survival of 5.2 versus 2.4?months (P?=?0.017) and time to treatment failure (4 vs. 1.8?months; P?=?0.007). Median overall survival was 10.1?months for HA-Irinotecan compared to 8.0?months for irinotecan patients (P?=?0.196). Conclusion Further studies are required to define the safety of the formulation of irinotecan with HA. While this study was not adequately powered to demonstrate survival differences, these phase II data indicated HA-Irinotecan to be a promising therapy demonstrating improved efficacy compared to irinotecan-alone. |
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