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Head and neck cancer, excluding thyroid

4798 - First-line Paclitaxel plus Carboplatin with/without Bevacizumab in Recurrent or Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomized, Open-label, Phase II Trial

Date

09 Sep 2017

Session

Head and neck cancer, excluding thyroid

Presenters

Li Zhang

Citation

Annals of Oncology (2017) 28 (suppl_5): v372-v394. 10.1093/annonc/mdx374

Authors

L. Zhang1, Y. Huang1, Y. Yang1, S. Ma1, X. Lin2, L. Lin3, T. Zhou4, Y. Deng5, C. Zhang6, X. Ding7, S. Wang8, R. Wang9, G. Feng10, Y. Chen11, R. Xu12

Author affiliations

  • 1 State Key Laboratory Of Oncology In South China, Collaborative Innovation Center For Cancer Medicine, Sun Yat-sen University Cancer Center, 510060 - Guangzhou/CN
  • 2 Medical Oncology, Sun Yat-Sen Memorial Hospital, Sun Yat-sen University, 510120 - guangzhou/CN
  • 3 Oncology, The First Affiliated Hospital of Guangdong University of Traditional Chinese Medicine, 510000 - guangzhou/CN
  • 4 Radiation Oncology, Cancer Center of Guangzhou Medical University, 510000 - guangzhou/CN
  • 5 Oncology, Foshan FirstPeople Hospital, 528000 - Foshan/CN
  • 6 Radiation Oncology, Dongguan People Hospital, 523000 - dongguan/CN
  • 7 Medical Oncology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Sun Yat-Sen University, 529000 - Jiangmen/CN
  • 8 Oncology, Peking University Shenzhen Hospital, 518000 - shenzhen/CN
  • 9 Radiation Oncology, The First Affiliated Hospital of Guangxi Medical University, 530000 - Guangxi/CN
  • 10 Oncology, The People's Hospital of Guangxi Zhuang Autonomous Region, 530000 - Guangxi/CN
  • 11 Medical Oncology, Hainan General Hospital, Hainan Clinical Medicine Research Institution, 570100 - Hainan/CN
  • 12 Medical Oncology, Shenzhen People's Hospital, Second Clinical Medical College of Jinan University, 510000 - Shenzhen/CN
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Resources

Abstract 4798

Background

This trial was conducted to investigate the efficacy and safety of paclitaxel plus carboplatin with/without bevacizumab in recurrent or metastatic nasopharyngeal carcinoma (NPC).

Methods

Patients with recurrent or metastatic NPC recruited from 12 hospitals in China were randomly assigned to receive carboplatin (area under the curve 6) and paclitaxel (175 mg/m2) intravenously on day 1 once per 3 weeks for a maximum of 6 cycles, with (CP+B) or without (CP) bevacizumab (7.5 mg/kg) intravenously on day 1 of each cycle, until disease progression, untolerable toxicity, or death. The primary endpoint was progression-free survival (PFS). Secondary end points were objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. This study is ongoing and registered with ClinicalTrials.gov (NCT02250599).

Results

Between Jun 8, 2015 and Jan 1, 2017, 80 patients were randomly assigned, 41 to the CP+B group and 39 to the CP group. ORR showed a numerical improvement with CP+B group (85.4% vs 69.2%) although with no statistical difference (p = 0.084). The median PFS was 7.23 months in the CP+B group and 7.00 months in the CP group (p = 0.506). OS had not yet matured. Safety was similar in two groups. No bevacizumab related serious adverse events were observed specially including bleeding.Table:

1052PD

EfficacyCP+B (n = 41)CP (n = 39)p
ORR [n (%)]35(85.4)27(69.2)0.084
DCR [n (%)]40(97.6)39(100%)1.000
PFS [m (95%CI)]7.23 (6.80, 8.71)7.00 (6.37, 8.41)0.506
Common drug-related AEsCP+B (n = 42)CP (n = 40)
All grades (%)Grade 3-4(%)All grades (%)Grade 3-4(%)
Leucopenia39(92.9)14(33.4)40(100)16(40)
Neutropenia33(78.7)16(38.2)40(100)21(52.5)
Aneamia29(69.1)7(16.7)27(67.5)2(5.0)
Thrombocytopenia23(54.8)1(2.4)20(50)1(2.5)
ALT increased10(23.9)2(4.8)12(30)0
AST increased5(12)09(22.5)0
Fatigue9(21.4)010(25)0
Peripheral neuropathy10(23.9)019(47.5)0
Nasal bleeding4(9.5)02(5)0
Hemoptysis1(2.4)02(5)0

Conclusions

CP+B regimen showed a numerical advantage in ORR among NPC patients. Given the limited sample size of our study, further research is needed to evaluate efficacy of bevacizumab in NPC.

Clinical trial identification

NCT02250599 Protocol Registration Receipt: 09/26/2014

Legal entity responsible for the study

the Institutional Review Board and academic committee of Sun Yat-Sen University Cancer Center

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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