NEW YORK (Reuters Health) Apr 06 - GOLFIG chemo-immunotherapy produced a better response rate and better progression-free survival than FOLFOX chemotherapy in patients with advanced colorectal cancer, researchers announced this week at the 102nd annual meeting of the American Association for Cancer Research (AACR).
Results with the chemo-immunotherapy regimen were so much better that the study was stopped early.
"This is the first clinical trial to demonstrate the efficacy of a chemo-immunological strategy for metastatic colon cancer treatment," lead investigator Dr. Pierpaolo Correale, from Siena University Santa Maria alle Scotte Hospital, Siena, Italy, told Reuters Health.
FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) is the standard treatment for advanced colorectal cancer. In a phase III trial, Dr. Correale and his team added gemcitabine to FOLFOX followed by granulocyte-macrophage colony stimulating factor and low-dose aldesleukine (GOLFIG) to boost the immune system.
The researchers randomized 130 patients to receive either GOLFIG or FOLFOX for a maximum of 12 cycles and then to receive maintenance treatment until disease progression.
"When we started the study, in September, 2005, the use of monoclonal antibodies was not considered as a standard treatment yet," Dr. Correale said.
More patients responded to GOLFIG than to FOLFOX -- 59.3% vs 34.4% (p = 0.0001), and progression-free survival was longer with the newer protocol: 12.4 vs 7.9 months (p = 0.0105).
That progression-free survival difference, discovered at the first pre-planned interim analysis, was what convinced the research team to stop the trial.
Adverse events were generally similar for both treatments and mostly consisted of grade I-II hematological toxicity, mucositis, and neurotoxicity. In the GOLFIG arm, 16% of patients had aldesleukine-related fever, and a similar percentage had self-limiting signs of autoimmunity. "These latter patients showed the best outcome, a finding which suggests the real involvement of the immune system in conditioning patients' outcomes," Dr. Correale said.
"Our study opens an interesting scenario for the research of new treatment strategies for colon cancer patients," he said. "It also offers a new and effective treatment alternative."
Overall, he added, "The combination of chemotherapy and immune-modulating agents is still an open research field that deserves much deeper investigation."
Results with the chemo-immunotherapy regimen were so much better that the study was stopped early.
"This is the first clinical trial to demonstrate the efficacy of a chemo-immunological strategy for metastatic colon cancer treatment," lead investigator Dr. Pierpaolo Correale, from Siena University Santa Maria alle Scotte Hospital, Siena, Italy, told Reuters Health.
FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) is the standard treatment for advanced colorectal cancer. In a phase III trial, Dr. Correale and his team added gemcitabine to FOLFOX followed by granulocyte-macrophage colony stimulating factor and low-dose aldesleukine (GOLFIG) to boost the immune system.
The researchers randomized 130 patients to receive either GOLFIG or FOLFOX for a maximum of 12 cycles and then to receive maintenance treatment until disease progression.
"When we started the study, in September, 2005, the use of monoclonal antibodies was not considered as a standard treatment yet," Dr. Correale said.
More patients responded to GOLFIG than to FOLFOX -- 59.3% vs 34.4% (p = 0.0001), and progression-free survival was longer with the newer protocol: 12.4 vs 7.9 months (p = 0.0105).
That progression-free survival difference, discovered at the first pre-planned interim analysis, was what convinced the research team to stop the trial.
Adverse events were generally similar for both treatments and mostly consisted of grade I-II hematological toxicity, mucositis, and neurotoxicity. In the GOLFIG arm, 16% of patients had aldesleukine-related fever, and a similar percentage had self-limiting signs of autoimmunity. "These latter patients showed the best outcome, a finding which suggests the real involvement of the immune system in conditioning patients' outcomes," Dr. Correale said.
"Our study opens an interesting scenario for the research of new treatment strategies for colon cancer patients," he said. "It also offers a new and effective treatment alternative."
Overall, he added, "The combination of chemotherapy and immune-modulating agents is still an open research field that deserves much deeper investigation."
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