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Randomized phase II study comparing weekly docetaxel-cisplatin vs. gemcitabine-cisplatin in elderly or poor performance status patients with advanced non-small cell lung cancer

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Abstract

Background

Docetaxel/cisplatin (DP) and gemcitabine/cisplatin (GP) are standard treatment regimens for advanced non-small cell lung cancer (NSCLC). In spite of potent efficacy, the conventional 1-day DP is regarded as having more toxicity as compared with GP. There is increasing interest in a biweekly split administration of DP to reduce its toxicity. Hypothesis was that first-line biweekly DP is as safe as GP in the elderly or poor performance status (PS) patients.

Methods

Chemotherapy-naïve patients with advanced NSCLC (IIIB/IV) who were elderly (65<) or PS (ECOG 2) were randomized to DP or GP arm by balancing for ECOG (0–1 vs. 2) and stage (IIIB vs. IV). DP comprised docetaxel (35 mg/m2)/cisplatin (30 mg/m2) iv on days 1 and 8, every 3 weeks. GP comprised gemcitabine (1000 mg/m2)/cisplatin (30 mg/m2) iv on days 1 and 8, every 3 weeks. Chemotherapy lasted up to 4–6 cycles or until progression. Primary endpoint was safety (proportion of grade 3/4 toxicities). Planned sample size was 49 patients in each arm.

Results

From November 2009 to August 2012, a total of 99 patients were randomized (DP 50/GP 49) from nine institutions. Adenocarcinoma and squamous cell carcinoma were observed in 62% and 33% of patients, respectively. Toxicity profiles were comparable for both arms and the differences were not statistically significant except for anemia and leucocytopenia. Any grade of anemia (86 vs. 98%) and of leucocytopenia (18 vs. 43%) was more common in the GP arm with statistical significance. Oral mucositis tended to be predominant in the DP arm. Patients in the DP arm (51%) suffered grade 3 or higher toxicities as did 47% in the GP arm (47%). The most common grade 3 or higher toxicities were as follows: In the DP arm, neutropenia (8%), leucopenia (8%), anemia (4%), pneumonia with normal ANC (4%) and febrile neutropenia (2%) were observed. In the GP arm, anemia (15%), neutropenia (15%), pneumonia with normal ANC (4%), thrombocytopenia (4%) and leucopenia (2%) were observed. The best overall response rates (CR + PR) for the DP and GP arms were 20.0 and 21% with no CR, respectively, and disease control rates (CR + PR + SD) were 70.0 and 76%, respectively. Median progression-free survival and median overall survival were 3.7 and 14.9 months in the DP arm and 5.6 and 20.8 months in the GP arm, respectively.

Conclusion

This study showed that DP is similar to GP in terms of efficacy and toxicity in treatment of elderly or poor performance patients. Both regimens showed similar grade 3/4 toxicities with different profiles.

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Authors and Affiliations

  1. Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, Republic of Korea

    JoungSoon Jang & Jong Wook Shin

  2. Department of Internal Medicine, St. Vincent’s Hospital, The Catholic University of Korea College of Medicine, Suwon, Republic of Korea

    Hoon-Kyo Kim & Chi-Hong Kim

  3. Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea

    Byoung Chul Cho

  4. Department of Internal Medicine, College of Medicine Yeungnam University, Daegu, Republic of Korea

    Kyung Hee Lee

  5. Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea

    Hwan-Jung Yun

  6. Department of Internal Medicine, Catholic University Yeouido St. Mary Hospital, Seoul, Republic of Korea

    In Sook Woo

  7. Department of Internal Medicine, Dongsan Medical center, Keimyung University, Daegu, Republic of Korea

    Hong Suk Song

  8. Department of Internal Medicine, Daegu Catholic University Medical Centre, Daegu, Republic of Korea

    Hun-Mo Ryoo

  9. Department of Internal Medicine, Uijungbu St. Mary’s Hospital, The Catholic Unviersity of Korea, Uijungbu, Republic of Korea

    Der-Sheng Sun

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  1. JoungSoon Jang
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Correspondence to Hoon-Kyo Kim.

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The authors declare that they have no conflict of interest.

Ethical approval

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Informed consent was obtained from all patients for being included in the study.

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Jang, J., Kim, HK., Cho, B.C. et al. Randomized phase II study comparing weekly docetaxel-cisplatin vs. gemcitabine-cisplatin in elderly or poor performance status patients with advanced non-small cell lung cancer. Cancer Chemother Pharmacol 79, 873–880 (2017). https://doi.org/10.1007/s00280-017-3289-6

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  • DOI: https://doi.org/10.1007/s00280-017-3289-6

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