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Supportive Care in Cancer

, Volume 24, Issue 2, pp 675–682 | Cite as

Efficacy and safety of olanzapine combined with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy in gynecological cancer: KCOG-G1301 phase II trial

  • Masakazu Abe
  • Yasuyuki Hirashima
  • Yuka Kasamatsu
  • Nobuhiro Kado
  • Satomi Komeda
  • Shiho Kuji
  • Aki Tanaka
  • Nobutaka Takahashi
  • Munetaka Takekuma
  • Hanako Hihara
  • Yoshikazu Ichikawa
  • Yui Itonaga
  • Tomoko Hirakawa
  • Kaei Nasu
  • Kanoko Miyagi
  • Junko Murakami
  • Kimihiko Ito
Original Article

Abstract

Purpose

Olanzapine is effective in chemotherapy-induced nausea and vomiting (CINV). In patients receiving highly emetogenic chemotherapy (HEC), its efficacy was reported as rescue therapy for breakthrough emesis refractory to triplet therapy (palonosetron, aprepitant, and dexamethasone). However, its preventive effects with triplet therapy for CINV are unknown. This study aimed to investigate efficacy and safety of preventive use of olanzapine with triplet therapy for CINV of HEC.

Methods

This study is a prospective multicenter study conducted by Kansai Clinical Oncology Group. Forty chemo-naïve gynecological cancer patients receiving HEC with cisplatin (≥50 mg/m2) were enrolled. Oral olanzapine (5 mg) was administered with triplet therapy a day prior to cisplatin administration and on days 1–5. The primary endpoint was complete response (no vomiting and no rescue) rate for the overall phase (0–120 h post-chemotherapy). Secondary endpoints were complete response rate for acute phase (0–24 h post-chemotherapy) and delayed phase (24–120 h post-chemotherapy) and complete control (no vomiting, no rescue, and no significant nausea) rate and total control (no vomiting, no rescue, and no nausea) rate for each phase. These endpoints were evaluated during the first cycle of chemotherapy.

Results

Complete response rates for acute, delayed, and overall phases were 97.5, 95.0, and 92.5 %, respectively. Complete control rates were 92.5, 87.5, and 82.5 %, respectively. Total control rates were 87.5, 67.5, and 67.5 %, respectively. There were no grade 3 or 4 adverse events.

Conclusions

Preventive use of olanzapine combined with triplet therapy gives better results than those from previously reported studies of triplet therapy.

Keywords

Olanzapine Chemotherapy-induced nausea and vomiting Cisplatin Highly-emetogenic chemotherapy Antiemetic therapy 

Notes

Acknowledgments

We would like to express our gratitude to Tatsuya Morita, M.D., from Seirei Mikatahara General Hospital, Satoru Iwase, M.D., from Tokyo University, and members of the KCOG for advising us regarding the creation of this trial protocol. The authors thank Crimson Interactive Pvt. Ltd. (Ulatus)—www.ulatus.jp—for their assistance in manuscript translation and editing.

Conflict of interest

The authors declare that they have no competing interests.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2015

Authors and Affiliations

  • Masakazu Abe
    • 1
  • Yasuyuki Hirashima
    • 1
  • Yuka Kasamatsu
    • 1
  • Nobuhiro Kado
    • 1
  • Satomi Komeda
    • 1
  • Shiho Kuji
    • 1
  • Aki Tanaka
    • 1
  • Nobutaka Takahashi
    • 1
  • Munetaka Takekuma
    • 1
  • Hanako Hihara
    • 2
  • Yoshikazu Ichikawa
    • 2
  • Yui Itonaga
    • 3
  • Tomoko Hirakawa
    • 3
  • Kaei Nasu
    • 3
  • Kanoko Miyagi
    • 4
  • Junko Murakami
    • 4
  • Kimihiko Ito
    • 4
  1. 1.Department of GynecologyShizuoka Cancer CenterShizuokaJapan
  2. 2.Department of Obstetrics and GynecologyJapanese Red Cross Shizuoka HospitalShizuoka CityJapan
  3. 3.Department of Obstetrics and Gynecology, Faculty of MedicineOita UniversityYufu CityJapan
  4. 4.Department of Obstetrics and GynecologyKansai Rousai HospitalAmagasaki-CityJapan

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