NEW YORK (Reuters Health) Dec 05 - Patients with early non-small-cell lung cancer (NSCLC) survive longer if they receive gemcitabine and cisplatin before radical surgery, according to a European study reported in the Journal of Clinical Oncology online.
The findings are from a phase III trial that was terminated early because other randomized trials had documented positive results with adjuvant chemotherapy, and the research team felt it would be unethical to continue with a surgery-only arm.
"This prematurely closed phase III study indicates estimates of efficacy outcome in the range of those reported in other trials of preoperative treatment in the same setting of patients," the authors comment.
Dr. Giorgio V. Scagliotti, with the University of Turin, Italy, and colleagues originally aimed to recruit 712 patients with stages IB-IIIA NSCLC to compare radical surgery alone to radical surgery preceded by three preoperative cycles of gemcitabine plus cisplatin. When the study was closed, 129 patients had been assigned to chemotherapy plus surgery and 141 to surgery only.
Progression-free survival at three years -- the primary end point -- was 52.9% for chemotherapy plus surgery and 47.9% with surgery alone, for a hazard ratio of 0.70 (p=0.003), the investigators report. Corresponding three-year overall survival rates were 67.6% versus 59.8% (hazard ratio 0.63; p=0.02).
The advantage was seen almost entirely in patients with stage IIB/IIIA NSCLC, for whom the survival benefit at three years was 23.4%, the authors point out. Differences in those with stage IB/IIA disease were nonsignificant.
Serious adverse events related to chemotherapy or the procedure occurred in 12% of patients in the combination arm and 8% in the surgery-only arm, according to the report. The rate of grade 3 or 4 hematologic toxicity was 32% in the chemo group, 0% in the surgery alone group. Corresponding rates of grade 3 or 4 non-hematologic events were 16% and 11%.
"This randomized, controlled, multicenter phase III study showed that preoperative chemotherapy in early-stage NSCLC was feasible, tolerable, and active," Dr. Scagliotti and colleagues conclude.
"Future developments in populations with these disease stages should focus on the utility of well-tolerated drugs and the collection of pharmacogenomic data to determine predictors for treatment outcome," they add.
But Dr. Gary M. Strauss with Tufts University School of Medicine in Boston, Massachusetts says in an editorial that "the evidence in support of surgical resection followed by adjuvant chemotherapy seems to be more convincing than for the use of induction chemotherapy in resectable NSCLC."
As for the current study, Dr. Strauss concludes, the findings "contribute only modestly to the question of how to optimally manage patients with resectable NSCLC."
SOURCE: http://bit.ly/vWn3i6
J Clin Oncol 2011.
The findings are from a phase III trial that was terminated early because other randomized trials had documented positive results with adjuvant chemotherapy, and the research team felt it would be unethical to continue with a surgery-only arm.
"This prematurely closed phase III study indicates estimates of efficacy outcome in the range of those reported in other trials of preoperative treatment in the same setting of patients," the authors comment.
Dr. Giorgio V. Scagliotti, with the University of Turin, Italy, and colleagues originally aimed to recruit 712 patients with stages IB-IIIA NSCLC to compare radical surgery alone to radical surgery preceded by three preoperative cycles of gemcitabine plus cisplatin. When the study was closed, 129 patients had been assigned to chemotherapy plus surgery and 141 to surgery only.
Progression-free survival at three years -- the primary end point -- was 52.9% for chemotherapy plus surgery and 47.9% with surgery alone, for a hazard ratio of 0.70 (p=0.003), the investigators report. Corresponding three-year overall survival rates were 67.6% versus 59.8% (hazard ratio 0.63; p=0.02).
The advantage was seen almost entirely in patients with stage IIB/IIIA NSCLC, for whom the survival benefit at three years was 23.4%, the authors point out. Differences in those with stage IB/IIA disease were nonsignificant.
Serious adverse events related to chemotherapy or the procedure occurred in 12% of patients in the combination arm and 8% in the surgery-only arm, according to the report. The rate of grade 3 or 4 hematologic toxicity was 32% in the chemo group, 0% in the surgery alone group. Corresponding rates of grade 3 or 4 non-hematologic events were 16% and 11%.
"This randomized, controlled, multicenter phase III study showed that preoperative chemotherapy in early-stage NSCLC was feasible, tolerable, and active," Dr. Scagliotti and colleagues conclude.
"Future developments in populations with these disease stages should focus on the utility of well-tolerated drugs and the collection of pharmacogenomic data to determine predictors for treatment outcome," they add.
But Dr. Gary M. Strauss with Tufts University School of Medicine in Boston, Massachusetts says in an editorial that "the evidence in support of surgical resection followed by adjuvant chemotherapy seems to be more convincing than for the use of induction chemotherapy in resectable NSCLC."
As for the current study, Dr. Strauss concludes, the findings "contribute only modestly to the question of how to optimally manage patients with resectable NSCLC."
SOURCE: http://bit.ly/vWn3i6
J Clin Oncol 2011.
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου