NEW YORK (Reuters Health) Dec 19 - When patients with advanced urothelial cancer can't receive cisplatin, carboplatin-based regimens are similarly effective, a phase II/III study shows.
Of the two carboplatin regimens tested, gemcitabine/carboplatin (GC) was more tolerable than methotrexate/carboplatin/vinblastine (M-CAVI), the researchers found.
Dr. Maria De Santis of Kaiser Franz Josef Hospital in Vienna, who headed the trial, told Reuters Health by email that the study "is the first of this kind in a clearly defined patient population that is not eligible for cisplatin standard chemotherapy."
Cisplatin is the standard of care, but renal impairment and poor performance status rule out its use in more than half of patients, Dr. De Santis and colleagues said in a December 12 online paper in the Journal of Clinical Oncology.
To evaluate carboplatin as an alternative, the researchers randomly assigned 238 chemotherapy-naive patients to treatment with GC or M-CAVI. It took seven years, and 29 hospitals, to accrue these patients, they note. All of the patients were ineligible for cisplatin-based treatment.
Over a median follow-up of 4.5 years, 41.2% of GC patients had a complete or partial response (including six unconfirmed responses), as did 30.3% of M-CAVI patients (with 11 unconfirmed responses).
The differences in overall and progression-free survival were not statistically significant between the groups, but they became significant when confirmed responses alone were considered.
Intent-to-treat analysis showed median overall survival rates of 9.3 months with GC and 8.1 months with M-CAVI. Progression-free survival rates with GC and M-CAVI were 5.8 and 4.2 months, respectively.
Despite the general similarity in outcome overall, more serious adverse events occurred with M-CAVI. That group had a significantly higher rate of death, thrombocytopenia with bleeding, renal toxicity, and other untoward events (21.2% vs 9.3%).
Dr. De Santis told Reuters Health: "Gemcitabine/carboplatin was less toxic than M-CAVI and will therefore become the preferred treatment option for cisplatin ineligible patients and the reference regimen for further trials."
SOURCE: http://bit.ly/vCXom2
J Clin Oncol 2011.
Of the two carboplatin regimens tested, gemcitabine/carboplatin (GC) was more tolerable than methotrexate/carboplatin/vinblastine (M-CAVI), the researchers found.
Dr. Maria De Santis of Kaiser Franz Josef Hospital in Vienna, who headed the trial, told Reuters Health by email that the study "is the first of this kind in a clearly defined patient population that is not eligible for cisplatin standard chemotherapy."
Cisplatin is the standard of care, but renal impairment and poor performance status rule out its use in more than half of patients, Dr. De Santis and colleagues said in a December 12 online paper in the Journal of Clinical Oncology.
To evaluate carboplatin as an alternative, the researchers randomly assigned 238 chemotherapy-naive patients to treatment with GC or M-CAVI. It took seven years, and 29 hospitals, to accrue these patients, they note. All of the patients were ineligible for cisplatin-based treatment.
Over a median follow-up of 4.5 years, 41.2% of GC patients had a complete or partial response (including six unconfirmed responses), as did 30.3% of M-CAVI patients (with 11 unconfirmed responses).
The differences in overall and progression-free survival were not statistically significant between the groups, but they became significant when confirmed responses alone were considered.
Intent-to-treat analysis showed median overall survival rates of 9.3 months with GC and 8.1 months with M-CAVI. Progression-free survival rates with GC and M-CAVI were 5.8 and 4.2 months, respectively.
Despite the general similarity in outcome overall, more serious adverse events occurred with M-CAVI. That group had a significantly higher rate of death, thrombocytopenia with bleeding, renal toxicity, and other untoward events (21.2% vs 9.3%).
Dr. De Santis told Reuters Health: "Gemcitabine/carboplatin was less toxic than M-CAVI and will therefore become the preferred treatment option for cisplatin ineligible patients and the reference regimen for further trials."
SOURCE: http://bit.ly/vCXom2
J Clin Oncol 2011.
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