Ramucirumab for Treating Advanced Gastric Cancer or Gastro-Oesophageal Junction Adenocarcinoma Previously Treated with Chemotherapy: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

Nasuh Büyükkaramikli1, Hedwig M. Blommestein1, Rob Riemsma2, Nigel Armstrong2, Fiona J. Clay3, Janine Ross2, Gill Worthy2, Johan L. Severens1, Jos Kleijnen2, Maiwenn Al1
1Institute for Medical Technology Assessment (iMTA), Institute of Health Policy and Management (iBMG), Erasmus University Rotterdam, Rotterdam, The Netherlands
2Kleijnen Systematic Reviews Ltd, York, UK
3Department of Psychiatry, University of Melbourne, Melbourne, Australia

Tóm tắt

Từ khóa


Tài liệu tham khảo

NICE. Guide to the single technology appraisal process, London, 2015. [Online]. https://www.nice.org.uk/process/pmg24/resources/single-technology-appraisal-user-guide-for-company-evidence-submission-template-pdf-72286715419333 . Accessed 08 Aug 2016.

NICE. Gastric cancer (metastatic)—ramucirumab (after chemotherapy) [ID741], NICE technology appraisal guidance [TA378], London, 2016. [Online]. https://www.nice.org.uk/guidance/indevelopment/gid-tag500 .Accessed 08 Aug 2016.

ONS. Cancer Registration Statistics, London, 2012. [Online]. https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/cancerregistrationstatisticsengland/2014-06-19#results . Accessed 06 June 2017.

Cancer Research UK. Stomach Cancer Incidence Statistics, Cancer Research UK, 2012. [Online]. http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/stomach-cancer/incidence . Accessed 08 Aug 2016.

Cancer Research UK, Stomach Cancer Mortality Statistics. Cancer Research UK, 2012. [Online]. http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/stomach-cancer/mortality . Accessed 08 Aug 2016.

Liepa AM et al. Real-world treatment patterns of previously treated advanced gastric and gastroesophageal junction adenocarcinoma (GC) in the United Kingdom (UK). In: Gastrointestinal Cancers Symposium, 2015.

NICE. Capecitabine for the Treatment of Advanced Gastric Cancer (TA 191), London, 2010. [Online]. https://www.nice.org.uk/Guidance/ta191 . Accessed 08 Aug 2016.

NICE. Trastuzumab for the treatment of HER2-positive metastatic gastric cancer, London, 2010. [Online]. https://www.nice.org.uk/guidance/TA208 . Accessed 08 Aug 2016.

Fuchs CS, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014;383(9911):31–9.

Aaronson NK, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365–76.

Wilke H, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224–35.

Sym SJ, et al. A randomized phase II study of biweekly irinotecan monotherapy or a combination of irinotecan plus 5-fluorouracil/leucovorin (mFOLFIRI) in patients with metastatic gastric adenocarcinoma refractory to or progressive after first-line chemotherapy. Cancer Chemother Pharmacol. 2013;71(2):481–8.

Ford HER, et al. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. Lancet Oncol. 2014;15(1):78–86.

Roy AC, et al. A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma. Ann Oncol. 2013;24(6):1567–73.

Hironaka S, et al. Randomized, open-label, phase III study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum: WJOG 4007 Tria. J Clin Oncol. 2013;31(35):4438–44.

Thuss-Patience PC, et al. Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer—a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Eur J Cancer. 2011;47(15):2306–14.

Kim J, et al. Race and ethnicity correlate with survival in patients with gastric adenocarcinoma. Ann Oncol Off J Eur Soc Med Oncol. 2010;21(1):152–60.

Kim R, Tan A, Choi M, El-Rayes BF. Geographic differences in approach to advanced gastric cancer: is there a standard approach? Crit Rev Oncol Hematol. 2013;88(2):416–26.

Ohtsu A, Yoshida S, Saijo N. Disparities in gastric cancer chemotherapy between the East and West. J Clin Oncol. 2006;24(14):2188–96.

Swinburn P, Lloyd A, Nathan P, Choueiri TK, Cella D, Neary MP. Elicitation of health state utilities in metastatic renal cell carcinoma. Curr Med Res Opin. 2010;26(5):1091–6.

Lloyd A, Nafees B, Narewska J, Dewilde S, Watkins J. Health state utilities for metastatic breast cancer. Br J Cancer. 2006;95(February):683–90.

Nafees B, Stafford M, Gavriel S, Bhalla S, Watkins J. Health state utilities for non small cell lung cancer. Health Qual Life Outcomes. 2008;6:84.

Coyle D, et al. Costs of palliative care in the community, in hospitals and in hospices in the UK. Crit Rev Oncol Hematol. 1999;32(2):71–85.

NICE. Technology appraisal guidance [TA306], Pixantrone monotherapy for treating multiply relapsed or refractory aggressive non-Hodgkin’s B-cell lymphoma, London, 2014. [Online]. https://www.nice.org.uk/guidance/ta306 . Accessed 08 Aug 2016.

Commercial Medicines Unit. Drugs and pharmaceutrical electronic Market Information (eMIT), 2014. [Online]. https://www.gov.uk/government/publications/drugs-and-pharmaceutical-electronic-market-information-emit . Accessed 23 Apr 2015.

Medicines Complete. British National Formulary [Internet]. 2015. https://www.medicinescomplete.com/mc/bnf/current/ . Accessed accessed 24 Apr 2015.

Kang JH, et al. Salvage chemotherapy for pretreated gastric cancer: a randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone. J Clin Oncol. 2012;30(13):1513–8.

National Institute for Health and Care Excellence. PMG19 Addendum A—Final amendments to the NICE technology appraisal processes and methods guides to support the proposed new Cancer Drugs Fund arrangements. Technology Appraisal Processes—CDF, London, 2016. [Online]. https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/process-and-methods-guide-addendum.pdf . Accessed 06 June 2016.