Phase II study of celecoxib with docetaxel chemoradiotherapy followed by consolidation chemotherapy docetaxel plus cisplatin with maintenance celecoxib in inoperable stage III nonsmall cell lung cancer |
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| Authors: | Harminder Takhar Nimit Singhal Anna Mislang Raj Kumar Laurence Kim Sid Selva‐Nayagam Ken Pittman Chris Karapetis Martin Borg Ian N. Olver Michael P. Brown |
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| Affiliation: | 1. Cancer Clinical Trials Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia;2. Department of Medical Oncology, Flinders Medical Centre and Flinders University, Adelaide, South Australia, Australia;3. Department of Medical Oncology, The Queen Elizabeth Hospital, Woodville, South Australia, Australia;4. Adelaide Radiotherapy Centre, Adelaide, South Australia, Australia;5. Sansom Institute, University of South Australia, Adelaide, South Australia, Australia;6. Centre for Cancer Biology, SA Pathology and University of South Australia, Adelaide, South Australia, Australia;7. Discipline of Medicine, University of Adelaide, Adelaide, South Australia, Australia |
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| Abstract: | 1 Title Phase II study of celecoxib with docetaxel chemoradiotherapy (CRT) followed by consolidation chemotherapy docetaxel plus cisplatin with maintenance celecoxib in inoperable stage III nonsmall cell lung cancer. 2 Introduction Concurrent CRT has been associated with improvement in absolute 5‐year survival by 10% and is the standard of care for inoperable stage III nonsmall cell lung cancer. Preclinical evidence suggests that cyclooxygenase‐2 inhibition may increase the efficacy of CRT. 3 Methods Patients were treated with CRT (weekly docetaxel at 30 mg/m2 over 6 weeks with concurrent external beam radiotherapy with 60 Gy in 30 fractions) followed by consolidation chemotherapy with docetaxel and cisplatin, each at 75 mg/m2 given 3 weekly for four cycles. Patients were to receive celecoxib 400 mg twice daily during treatment. Prophylactic cranial irradiation (30 Gy in 15 fractions) was offered if there was disease response. 4 Results Twenty‐four patients commenced CRT. Nineteen patients commenced consolidation therapy with 14 patients completing treatment. Twelve patients had treatment with celecoxib. In the total cohort, the median overall survival (mOS) was 21 months and progression‐free survival (PFS) was 16 months. Overall response rate was 59% and disease control rate was 82%. Three patient deaths occurred. Significant grade 3/4 toxicity included radiation pneumonitis (17%), febrile neutropenia (17%), infection/sepsis with or with neutropenia (25%) and esophagitis (12.5%). Retrospective analysis of celecoxib versus no celecoxib treatment showed favorable mOS 26.5 versus 17.5 months and PFS 22 versus 16 months, but this did not reach statistical significance. 5 Conclusions The activity of this regimen has been demonstrated. Treatment‐related toxicity was substantial. The role of celecoxib in addition to CRT could not be demonstrated in this study because of the small number of patients. |
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| Keywords: | celecoxib chemotherapy locally advanced lung cancer radiotherapy |
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