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Pemetrexed in combination with cisplatin versus cisplatin monotherapy in E ast A sian patients with recurrent or metastatic head and neck cancer: Results of an exploratory subgroup analysis of a phase III trial
Author(s) -
Urba Susan,
Hong RueyLong,
Hossain Anwar M,
Cheng Rebecca,
Orlando Mauro
Publication year - 2013
Publication title -
asia‐pacific journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.73
H-Index - 29
eISSN - 1743-7563
pISSN - 1743-7555
DOI - 10.1111/ajco.12060
Subject(s) - cisplatin , subgroup analysis , exploratory analysis , medicine , pemetrexed , head and neck cancer , oncology , head and neck , cancer , chemotherapy , confidence interval , surgery , computer science , data science
Abstract Aim: An exploratory subgroup analysis of E ast A sian ( EA ) patients in a phase III trial was conducted to assess efficacy and safety trends based on ethnicity. Methods: The 795 patients with recurrent or metastatic squamous cell carcinoma of the head and neck included 111 EA patients randomized to pemetrexed‐cisplatin ( n = 55) and placebo‐cisplatin ( n = 56) and 684 non‐ EA patients randomized to pemetrexed‐cisplatin ( n = 343) and placebo‐cisplatin ( n = 341). Treatment differences in median overall survival and progression‐free survival were compared using a stratified log–rank test. Survival was estimated using the K aplan– M eier method. Results: The median overall survival in the pemetrexed‐cisplatin and placebo‐cisplatin arms of the EA group (6.8 and 5.7 months, respectively [ P = 0.275]) was similar to that in the global population (7.3 and 6.3 months, respectively [ P = 0.082]); the median progression‐free survival in the pemetrexed‐cisplatin and placebo‐cisplatin arms in the EA group (2.8 and 1.9 months, respectively [ P = 0.748]) was similar to that in the global population (3.6 and 2.8 months, respectively [ P = 0.166]). Compared to the findings in the global population, overall survival for the EA group receiving prior platinum‐based therapy was longer ( P = 0.042 vs P = 0.065). There was no significant interaction between treatment arms and ethnicity. Conclusion: Consistent with findings in the global population, pemetrexed‐cisplatin did not improve survival compared with placebo‐cisplatin for the EA group . However, in a subgroup analysis, pemetrexed‐cisplatin showed an overall survival advantage in EA patients receiving prior platinum‐based therapy.