Adding induction chemotherapy to standard
concurrent chemoradiotherapy boosted overall survival in patients with
high-risk locoregionally advanced nasopharyngeal carcinoma, but at a
cost of higher rates of acute grade 3 or 4 toxicities, in a phase 3
study conducted in China.
"The increase from 90.3% to 94.6% in overall survival is a big jump. It means the new treatment lowered the risk of death by about 50% " Jun Ma, MD, of the Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Quangzhou, China, told Medscape Medical News.
As for side effects, "most acute side effects were temporary and reversible [and] would not significantly impair the patient's quality of life. The incidence of late side effects was not increased with the induction chemotherapy, with the exception of mild peripheral neuropathy," Ma said.
Approached for comment, Marcelo Bonomi, MD, of the Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital, Columbus, said the study has already changed practice at his institution, where use of induction chemotherapy is now standard in these patients.
The absolute benefit in overall survival is "huge," and acute toxicity is the "price to pay" for improved overall survival, Bonomi told Medscape Medical News.
The study was published online September 19 in the New England Journal of Medicine and was presented earlier this year at the annual meeting of the American Society of Clinical Oncology.
In their study, the investigators explored adding induction chemotherapy with gemcitabine and cisplatin, which had already shown promising efficacy in phase 2 trials.
Theirs was a phase 3 study, conducted in 480 patients with previously untreated, locoregionally advanced, nonmetastatic stage III–IVB nasopharyngeal carcinoma.
Roughly half of the patients were randomly allocated to receive induction chemotherapy with gemcitabine (1 g/m2 on days 1 and 8) plus cisplatin (80 mg/m2 on day 1), administered every 3 weeks for three cycles, plus chemoradiotherapy (concurrent cisplatin at a dose of 100 mg/m2 every 3 weeks for three cycles plus intensity-modulated radiotherapy).
The patients in the other group were treated with chemoradiotherapy alone.
At a median follow-up of 42.7 months, the primary endpoint of 3-year recurrence-free survival was 85.3% with induction chemotherapy vs 76.5% with chemoradiotherapy alone (stratified hazard ratio for recurrence or death, 0.51; 95% confidence interval [CI], 0.34 – 0.77; P = .001).
"The increase from 90.3% to 94.6% in overall survival is a big jump. It means the new treatment lowered the risk of death by about 50% " Jun Ma, MD, of the Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Quangzhou, China, told Medscape Medical News.
As for side effects, "most acute side effects were temporary and reversible [and] would not significantly impair the patient's quality of life. The incidence of late side effects was not increased with the induction chemotherapy, with the exception of mild peripheral neuropathy," Ma said.
Approached for comment, Marcelo Bonomi, MD, of the Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital, Columbus, said the study has already changed practice at his institution, where use of induction chemotherapy is now standard in these patients.
The absolute benefit in overall survival is "huge," and acute toxicity is the "price to pay" for improved overall survival, Bonomi told Medscape Medical News.
The study was published online September 19 in the New England Journal of Medicine and was presented earlier this year at the annual meeting of the American Society of Clinical Oncology.
Clear-cut Survival Advantage
The authors explain that, at presentation, 70% of patients with nasopharyngeal carcinoma have locoregionally advanced disease and an unfavorable prognosis. Chemoradiotherapy with a platinum-based agent is the backbone of therapy in this group.In their study, the investigators explored adding induction chemotherapy with gemcitabine and cisplatin, which had already shown promising efficacy in phase 2 trials.
Theirs was a phase 3 study, conducted in 480 patients with previously untreated, locoregionally advanced, nonmetastatic stage III–IVB nasopharyngeal carcinoma.
Roughly half of the patients were randomly allocated to receive induction chemotherapy with gemcitabine (1 g/m2 on days 1 and 8) plus cisplatin (80 mg/m2 on day 1), administered every 3 weeks for three cycles, plus chemoradiotherapy (concurrent cisplatin at a dose of 100 mg/m2 every 3 weeks for three cycles plus intensity-modulated radiotherapy).
The patients in the other group were treated with chemoradiotherapy alone.
At a median follow-up of 42.7 months, the primary endpoint of 3-year recurrence-free survival was 85.3% with induction chemotherapy vs 76.5% with chemoradiotherapy alone (stratified hazard ratio for recurrence or death, 0.51; 95% confidence interval [CI], 0.34 – 0.77; P = .001).
Adding induction chemotherapy to standard
concurrent chemoradiotherapy boosted overall survival in patients with
high-risk locoregionally advanced nasopharyngeal carcinoma, but at a
cost of higher rates of acute grade 3 or 4 toxicities, in a phase 3
study conducted in China.
"The increase from 90.3% to 94.6% in overall survival is a big jump. It means the new treatment lowered the risk of death by about 50% " Jun Ma, MD, of the Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Quangzhou, China, told Medscape Medical News.
As for side effects, "most acute side effects were temporary and reversible [and] would not significantly impair the patient's quality of life. The incidence of late side effects was not increased with the induction chemotherapy, with the exception of mild peripheral neuropathy," Ma said.
Approached for comment, Marcelo Bonomi, MD, of the Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital, Columbus, said the study has already changed practice at his institution, where use of induction chemotherapy is now standard in these patients.
The absolute benefit in overall survival is "huge," and acute toxicity is the "price to pay" for improved overall survival, Bonomi told Medscape Medical News.
The study was published online September 19 in the New England Journal of Medicine and was presented earlier this year at the annual meeting of the American Society of Clinical Oncology.
In their study, the investigators explored adding induction chemotherapy with gemcitabine and cisplatin, which had already shown promising efficacy in phase 2 trials.
Theirs was a phase 3 study, conducted in 480 patients with previously untreated, locoregionally advanced, nonmetastatic stage III–IVB nasopharyngeal carcinoma.
Roughly half of the patients were randomly allocated to receive induction chemotherapy with gemcitabine (1 g/m2 on days 1 and 8) plus cisplatin (80 mg/m2 on day 1), administered every 3 weeks for three cycles, plus chemoradiotherapy (concurrent cisplatin at a dose of 100 mg/m2 every 3 weeks for three cycles plus intensity-modulated radiotherapy).
The patients in the other group were treated with chemoradiotherapy alone.
At a median follow-up of 42.7 months, the primary endpoint of 3-year recurrence-free survival was 85.3% with induction chemotherapy vs 76.5% with chemoradiotherapy alone (stratified hazard ratio for recurrence or death, 0.51; 95% confidence interval [CI], 0.34 – 0.77; P = .001).
"The increase from 90.3% to 94.6% in overall survival is a big jump. It means the new treatment lowered the risk of death by about 50% " Jun Ma, MD, of the Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Quangzhou, China, told Medscape Medical News.
As for side effects, "most acute side effects were temporary and reversible [and] would not significantly impair the patient's quality of life. The incidence of late side effects was not increased with the induction chemotherapy, with the exception of mild peripheral neuropathy," Ma said.
Approached for comment, Marcelo Bonomi, MD, of the Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital, Columbus, said the study has already changed practice at his institution, where use of induction chemotherapy is now standard in these patients.
The absolute benefit in overall survival is "huge," and acute toxicity is the "price to pay" for improved overall survival, Bonomi told Medscape Medical News.
The study was published online September 19 in the New England Journal of Medicine and was presented earlier this year at the annual meeting of the American Society of Clinical Oncology.
Clear-cut Survival Advantage
The authors explain that, at presentation, 70% of patients with nasopharyngeal carcinoma have locoregionally advanced disease and an unfavorable prognosis. Chemoradiotherapy with a platinum-based agent is the backbone of therapy in this group.In their study, the investigators explored adding induction chemotherapy with gemcitabine and cisplatin, which had already shown promising efficacy in phase 2 trials.
Theirs was a phase 3 study, conducted in 480 patients with previously untreated, locoregionally advanced, nonmetastatic stage III–IVB nasopharyngeal carcinoma.
Roughly half of the patients were randomly allocated to receive induction chemotherapy with gemcitabine (1 g/m2 on days 1 and 8) plus cisplatin (80 mg/m2 on day 1), administered every 3 weeks for three cycles, plus chemoradiotherapy (concurrent cisplatin at a dose of 100 mg/m2 every 3 weeks for three cycles plus intensity-modulated radiotherapy).
The patients in the other group were treated with chemoradiotherapy alone.
At a median follow-up of 42.7 months, the primary endpoint of 3-year recurrence-free survival was 85.3% with induction chemotherapy vs 76.5% with chemoradiotherapy alone (stratified hazard ratio for recurrence or death, 0.51; 95% confidence interval [CI], 0.34 – 0.77; P = .001).
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