ASCO Annual Meeting

ASCO Annual Meeting

June 01, 2019
2 min read
Save

Induction chemotherapy improves outcomes in locoregionally advanced nasopharyngeal carcinoma

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

CHICAGO — The addition of gemcitabine and cisplatin induction chemotherapy to concurrent chemoradiotherapy significantly improved RFS among patients with locoregionally advanced nasopharyngeal carcinoma, according to results of a randomized phase 3 trial presented at ASCO Annual Meeting.

The regimen also exhibited a favorable toxicity profile, researchers concluded.

“Nasopharyngeal carcinoma is a unique head and neck cancer with a propensity of distant metastasis,” Jun Ma, MD, deputy president of radiation oncology at Sun Yat-sen University Cancer Center in China, said during his presentation. “Current standard of care for locoregionally advanced nasopharyngeal carcinoma is concurrent platinum-based chemoradiotherapy with or without adjuvant chemotherapy. Systemic intensification strategies are crucial in targeting distant metastatic relapses.”

Gemcitabine and cisplatin is a standard first-line treatment option for patients with recurrent or metastatic nasopharyngeal carcinoma. However, its value for patients with locoregionally advanced disease had not been established, according to study background.

Ma and colleagues hypothesized that gemcitabine and cisplatin doublet could be effective when added to concurrent cisplatin-radiotherapy given that upfront gemcitabine-cisplatin targets occult distant metastasis in high-risk nasopharyngeal carcinoma, reduces risk for distant metastasis and improves RFS.

The multicenter trial that included 480 patients aged 18 to 64 years with previously untreated, nonmetastatic stage III to stage IVB nasopharyngeal carcinoma.

The patients, from 12 centers, had no severe comorbidities. Those with T3-4N0M0 disease were excluded.

Researchers assigned 238 patients to concurrent chemoradiotherapy alone, which consisted of cisplatin 100 mg/m² every 3 weeks for three cycles plus intensity-modulated radiotherapy. The other 242 patients received concurrent chemoradiotherapy with gemcitabine (1 g/m2 on days 1 and 8) and cisplatin (80 mg/m2 on day 1 every 3 weeks for three cycles).

Baseline characteristics were well-balanced between groups.

RFS served as the primary endpoint. Ma and colleagues calculated a sample size of 238 patients per group, with 80% power to detect a treatment failure HR of 0.52.

Secondary endpoints included OS, distant RFS, locoregional RFS, response rate, treatment compliance and toxicity profile.

The majority of patients who started induction chemotherapy completed all three cycles (96.7%; n = 231 of 239).

Median follow-up was 39 months.

Results showed a significantly improved 3-year RFS rate in the induction chemotherapy group (85.3% vs. 76.5%; HR = 0.51; 95% CI, 0.34-0.77).

Researchers also reported significantly higher rates of 3-year OS (94.6% vs. 90.3%; P = .02) and 3-year distant RFS (91.1% vs. 84.4%; stratified HR = 0.43; 95% CI, 0.25-0.73) in the induction chemotherapy group.

PAGE BREAK

More than one-third (38.9%) of patients assigned induction chemotherapy experienced grade 3 or higher adverse events during induction. A higher percentage of patients assigned induction chemotherapy experienced grade 3 or higher adverse events during concurrent chemoradiotherapy (65.3% vs. 55.3%; P = .03).

Patients assigned induction chemotherapy appeared more likely to experience grade 3 or higher neutropenia (28% vs. 10.5%) or leukopenia (26.4% vs. 20.3%). The rate of grade 3 or higher mucositis was higher among patients assigned concurrent radiotherapy alone (32.1% vs. 28.9%).

However, researchers reported no difference between groups in late adverse events and no difference in cisplatin-related toxicities despite a high cumulative dose of cisplatin (median, 440 mg/m2).

“Induction gemcitabine-cisplatin plus concurrent chemoradiotherapy improved disease control and OS compared with concurrent chemoradiotherapy [alone] in high-risk, locally advanced nasopharyngeal carcinoma,” Ma said during his presentation. “We show that doublet gemcitabine-cisplatin is tolerable and [has] a high compliance rate. This trial establishes [this regimen] as the standard of care in locally advanced nasopharyngeal carcinoma. Induction gemcitabine-cisplatin plus concurrent chemoradiotherapy can be an option for first-line treatment in this high-risk subgroup.” – by Mark Leiser

 

Reference:

Ma J, et al. Abstract 6003. Presented at: ASCO Annual Meeting; May 31-June 4, 2019; Chicago.

 

Disclosures: The authors report no relevant financial disclosures.