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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

2555 - Docetaxel plus ramucirumab with primary prophylactic pegylated-granulocyte-colony stimulating factor for pretreated non-small cell lung cancer

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Topics

Cytotoxic Therapy;  Immunotherapy

Tumour Site

Presenters

Daijiro Harada

Citation

Annals of Oncology (2018) 29 (suppl_8): viii493-viii547. 10.1093/annonc/mdy292

Authors

D. Harada1, A. Hata2, C. Okuda2, R. Kaji2, Y. Masuda3, Y. Takechi4, T. Kozuki1, N. Nogami1, N. Katakami2

Author affiliations

  • 1 Department Of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, 791-0280 - Matsuyama/JP
  • 2 Department Of Medical Oncology, Kobe City Medical Center General Hospital, 650-0047 - Kobe/JP
  • 3 Department Of Pharmacy, Kobe City Medical Center General Hospital, 650-0047 - Kobe/JP
  • 4 Department Of Pharmacy, National Hospital Organization Shikoku Cancer Center, 791-0280 - Matsuyama/JP

Resources

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Abstract 2555

Background

A Japanese randomized phase II trial comparing docetaxel plus ramucirumab with docetaxel monotherapy (JVCG) showed that effectiveness of additional ramucirumab was comparable to that of a randomized phase III trial (REVEL). However, in the JVCG study, febrile neutropenia (FN) was confirmed in 34% of the patients in the combination arm. It was assumed that the high frequency of FN was related to the fact that preventive prophylactic pegylated (PEG)-granulocyte-colony stimulating factor (G-CSF) was administered to only 6% of the patients. The aim of our study was to evaluate the efficacy and safety of docetaxel plus ramucirumab with primary prophylactic PEG-G-CSF for Japanese pretreated non-small cell lung cancer (NSCLC).

Methods

We retrospectively reviewed medical records of pretreated NSCLC cases who had received docetaxel plus ramucirumab in our departments.

Results

Sixty-one pretreated NSCLC patients underwent docetaxel plus ramucirumab. Primary prophylactic PEG-G-CSF was performed in 52 (85%) patients (prophylactic group). No FN (0%) was confirmed in 52 prophylactic group patients, whereas FN was observed in 3 (33%) of 9 non-prophylactic group patients. Among prophylactic group, median lines of prior therapy was 2 (range, 1-9). Median cycles of docetaxel plus ramucirumab was 3 (range, 1-25) (9 and 3 cases moved to ramucirumab and docetaxel monotherapies, respectively). Response rate and disease control rate were 30.8% and 73.1%, respectively. Median progression-free survival was 4.5 (95% confidence interval [CI], 3.0-6.6) months. Median overall survival was 11.4 (95% CI, 8.0-13.9) months. Six (11.5%) patients had grade 3/4 neutropenia. Observed grade 3 (incidence ≥10%) adverse event (AE) was oral mucositis (13.5%). There were no grade 4/5 non-hematological AEs.

Conclusions

Our study demonstrated the efficacy and safety of docetaxel plus ramucirumab with PEG-G-CSF. Primary prophylactic PEG-G-CSF could markedly reduce incidence of FN in Japanese clinical practice.

Clinical trial identification

Legal entity responsible for the study

Akito Hata.

Funding

Has not received any funding.

Editorial Acknowledgement

We thank Ayami Asakawa, Mizuho Awaki, Suemi Minamihara, Hiroko Ishikawa and Mamiya Atagi for their assistance, and Mr. David Martin for writing support.

Disclosure

D. Harada: Lecture fees: Ono, Bristol-Myers Squibb, Yakult Honsha, Kyowa Hakko Kirin, AstraZeneca, Nippon Boehringer Ingelheim, Eli Lilly Japan. A. Hata: Lecture fees: Chugai, AstraZeneca, Boeringer Ingelheim, Eli Lilly. T. Kozuki: Honoraria: Chugai, AstraZeneca, Eli Lilly Japan, Boehringer Ingelheim, Ono, Bristol-Myers Squibb, Taiho, MSD, Pfizer, Kyowa Hakko Kirin; Research funding: Chugai, AstraZeneca, MSD, Eli Lilly Japan. N. Nogami: Honoraria: Astellas, AstraZeneca, Ono, Taiho, Chugai, Eli Lilly, Boehringer Ingelheim, Pfizer. N. Katakami: Grants: AstraZeneca, Eisai, Ono, Kyowa Kirin, Shionogi, Daiichi-Sankyo, Taiho, Chugai, Eli Lilly, Boeringer Ingelheim, Merck Serono; Payment for lectures: Dainippon Sumitomo, Chugai, Boeringer Ingelheim, AstraZeneca, Eli Lilly, Taiho, Janssen, Novartis, Pfizer, Ono, Daiichi-Sankyo. All other authors have declared no conflicts of interest.

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