March 9, 2011 (San Antonio, Texas) — Radiofrequency ablation (RFA) raises the survival rates in patients already receiving chemotherapy for the treatment of metastatic liver disease, researchers reported here at the Society of Surgical Oncology 64th Annual Cancer Symposium.
"Our aim was to assess the safety and efficacy of radiation in combination with chemotherapy in patients with colorectal liver metastases. It was originally designed as a phase 3 study," reported Theo Ruers, MD, professor of surgical oncology at the Netherlands Cancer Institute in Amsterdam.
Instead, the researchers conducted a phase 2 analysis to determine progression-free survival and toxicity (NCT00043004). "This is the first study that prospectively investigates the efficacy of RFA in combination with chemotherapy." Dr. Ruers reported.
The randomized trial evaluated the benefits of adding RFA to systemic chemotherapy in patients with 9 or fewer unresectable colorectal liver metastases and no extrahepatic disease in 119 patients enrolled from 2002 to 2007. Patients were treated with either RFA + chemotherapy or chemotherapy alone. In both groups, chemotherapy consisted of 10 cycles of FOLFOX (leucovorin, 5-fluorouracil, and oxaliplatin) plus bevacizumab; toxicity profiles were comparable.
The primary end point — more than 38% with overall survival of 30 months — was met, but 30-month overall survival in the chemotherapy group was also much higher than 38%. However, Dr. Ruers reported, "progression-free survival was significantly longer in the RFA + chemotherapy arm than in the chemotherapy-alone arm."
At a median follow-up of 4.4 years, the 30-month overall survival rate was 61.7% (95% confidence interval [CI], 48.21 to 73.93) in the RFA + chemotherapy group and 57.6% (95% CI, 44.07 to 70.39) in the chemotherapy-only group.
Median progression-free survival, a secondary end point, was 16.8 months in the RFA + chemotherapy group (95% CI, 11.7 to 22.1) and 9.9 months (95% CI, 9.3 to 13.7) in the chemotherapy-only group (P = .025).
James Economou, MD, incoming SSO president, who moderated the meeting's opening session, noted that the study is important because it was "the first attempt at a randomized trial. . . . It has been difficult to sort out the different effects from the 2 treatments."
The trial was supported by grants from Cancer Research UK, ALM-CAO (Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie), the Dutch Cancer Foundation (Commissie Klinisch Toegepast Onderzoek), and the National Cancer Institute; by a donation from the Kankerbestrijding/KWF from the Netherlands through the EORTC Charitable Trust; and by an unrestricted scientific grant from Sanofi-Aventis. Radionics, Radiotherapeutics, and Rita provided free RFA needles. The researchers have disclosed no relevant financial relationships.
Society of Surgical Oncology (SSO) 64th Annual Cancer Symposium. Presented March 4, 2011.
"Our aim was to assess the safety and efficacy of radiation in combination with chemotherapy in patients with colorectal liver metastases. It was originally designed as a phase 3 study," reported Theo Ruers, MD, professor of surgical oncology at the Netherlands Cancer Institute in Amsterdam.
Instead, the researchers conducted a phase 2 analysis to determine progression-free survival and toxicity (NCT00043004). "This is the first study that prospectively investigates the efficacy of RFA in combination with chemotherapy." Dr. Ruers reported.
The randomized trial evaluated the benefits of adding RFA to systemic chemotherapy in patients with 9 or fewer unresectable colorectal liver metastases and no extrahepatic disease in 119 patients enrolled from 2002 to 2007. Patients were treated with either RFA + chemotherapy or chemotherapy alone. In both groups, chemotherapy consisted of 10 cycles of FOLFOX (leucovorin, 5-fluorouracil, and oxaliplatin) plus bevacizumab; toxicity profiles were comparable.
The primary end point — more than 38% with overall survival of 30 months — was met, but 30-month overall survival in the chemotherapy group was also much higher than 38%. However, Dr. Ruers reported, "progression-free survival was significantly longer in the RFA + chemotherapy arm than in the chemotherapy-alone arm."
At a median follow-up of 4.4 years, the 30-month overall survival rate was 61.7% (95% confidence interval [CI], 48.21 to 73.93) in the RFA + chemotherapy group and 57.6% (95% CI, 44.07 to 70.39) in the chemotherapy-only group.
Median progression-free survival, a secondary end point, was 16.8 months in the RFA + chemotherapy group (95% CI, 11.7 to 22.1) and 9.9 months (95% CI, 9.3 to 13.7) in the chemotherapy-only group (P = .025).
James Economou, MD, incoming SSO president, who moderated the meeting's opening session, noted that the study is important because it was "the first attempt at a randomized trial. . . . It has been difficult to sort out the different effects from the 2 treatments."
The trial was supported by grants from Cancer Research UK, ALM-CAO (Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie), the Dutch Cancer Foundation (Commissie Klinisch Toegepast Onderzoek), and the National Cancer Institute; by a donation from the Kankerbestrijding/KWF from the Netherlands through the EORTC Charitable Trust; and by an unrestricted scientific grant from Sanofi-Aventis. Radionics, Radiotherapeutics, and Rita provided free RFA needles. The researchers have disclosed no relevant financial relationships.
Society of Surgical Oncology (SSO) 64th Annual Cancer Symposium. Presented March 4, 2011.
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