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Guadagno di sopravvivenza dei nuovi farmaci

Survival gain with new drugs

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PharmacoEconomics Italian Research Articles

Summary

Objective

Since the so-called survival gain is recognised to be a parameter that quantifies the magnitude of the therapeutic benefit of new treatments, our study is aimed at reviewing the literature on this parameter published over the past years.

Methods

To select the pertinent articles, we conducted a literature search using MEDLINE (PubMed version). We utilised the key word “survival analysis” (as a Mesh term) with the following limits: a) publication date from 2001 to 2002, b) “randomized controlled trial”, c) “only items with abstracts”, d) “English”; e) “human”. We identified all the studies that reported the value of median survival for both treatments groups. In addition, for the clinical studies that did not explicitly report this parameter, we conducted a separate literature search to verify if a cost-effectiveness analysis could be found wherein the “mean survival gain” of the new treatment had been calculated in comparison to the standard drug. Irrespective of their source, the value of survival gain were finally tabulated and arranged by decreasing order.

Results

Twenty-nine articles were included in our study. From these articles, we extracted the value of median survival gain in 28 cases and the value of mean survival gain in one case; 27 studies evaluated anti-cancer drugs, whereas two considered treatments aimed at other disease conditions. The survival gain ranged from some months per patient (for the majority of therapies) up to a maximum of 84 months per patient; the latter value of survival gain was obtained for all-trans retinoic acid in the treatment of acute promyelocytic leukemia. With regard to disease conditions other than cancer, we found a survival gain of 6 months per patient for activated protein C in the treatment of severe sepsis.

Conclusion

Our study tabulated the survival gain for a variety of recent medical interventions. According to our findings, the typical value of survival gain for new treatments (with the exception of all-trans retinoic acid) is in the range of some months per patient. This confirms the results presented in a previous analysis focused on the literature of the’ 90s.

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Bibliografia

  1. Wright JC, Weinstein MC. Gains in life expectancy from medical interventions: standardizing data on outcomes. N Engl J Med 1998; 339: 380–6

    Article  PubMed  CAS  Google Scholar 

  2. Messori A, Becagli P, Trippoli S. Median versus mean lifetime survival in the analysis of survival data. Haematologica 1997; 82(6): 730

    PubMed  CAS  Google Scholar 

  3. Messori A, Trippoli S, Vaiani M. Cost-effectiveness of innovative anti-cancer drugs (Letter). eBMJ, 5 August 2002, web address: http://bmj.com/cgi/eletters/325/7358/269#24426

  4. Italian Cooperative Study Group on Chronic Myeloid Leukemia. Interferon alpha-2a as compared with conventional chemotherapy for the treatment of chronic myeloid leukemia. N Engl J Med 1994; 330: 820–25

    Article  Google Scholar 

  5. Messori A. Cost-effectiveness of interferon in chronic myeloid leukaemia: analysis of four clinical studies. Ann Oncol 1998; 9(4): 389–96

    Article  PubMed  CAS  Google Scholar 

  6. Tallman MS, Andersen JW, Schiffer CA, et al. All-trans retinoic acid in acute promyelocytic leukemia: long-term outcome and prognostic factor analysis from the North American Intergroup protocol. Blood 2002; 100(13): 4298–302

    Article  PubMed  CAS  Google Scholar 

  7. French Adjuvant Study Group. Benefit of a high-dose epirubicin regimen in adjuvant chemotherapy for node-positive breast cancer patients with poor prognostic factors: 5-year follow-up results of French Adjuvant Study Group 05 randomized trial. J Clin Oncol 2001; 19(3): 602–11

    Google Scholar 

  8. Frustaci S, Gherlinzoni F, De Paoli A, et al. Adjuvant chemotherapy for adult soft tissue sarcoma of the extremities and girdles; results of the Italian randomized cooperative trial. J Clin Oncol 2001; 19: 1238–47

    PubMed  CAS  Google Scholar 

  9. Hancock BW, Gregory WM, Cullen MH, et al.; British National Lymphoma Investigation; Central Lymphoma Group. ChIVPP alternating with PABIOE is superior to PABIOE alone in the initial treatment of advanced Hodgkin’s disease: results of a British National Lymphoma Investigation/Central Lymphoma Group randomized controlled trial. Br J Cancer 2001; 84(10): 1293–300

    Article  PubMed  CAS  Google Scholar 

  10. Mainwaring PN, Cunningham D, Gregory W, et al. Mitoxantrone is superior to doxorubicin in a multiagent weekly regimen for patients older than 60 with high-grade lymphoma: results of a BNLI randomized trial of PAdriaCEBO versus PMitCEBO. Blood 2001; 97(10): 2991–7

    Article  PubMed  CAS  Google Scholar 

  11. Lygidakis NJ, Sgourakis G, Vlachos L, et al. Metastatic liver disease of colorectal origin: the value of locoregional immunochemotherapy combined with systemic chemotherapy following liver resection. Results of a prospective randomized study. Hepatogastroenterology 2001; 48: 1685–91

    PubMed  CAS  Google Scholar 

  12. Coiffier B, Lepage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med 2002; 346(4): 235–42

    Article  PubMed  CAS  Google Scholar 

  13. Lygidakis NJ, Sgourakis G, Giorgia D, et al. Regional targeting chemoimmunotherapy in patients undergoing pancreatic resection in an advanced stage of their disease. Ann Surg 2002; 236: 806–13

    Article  PubMed  Google Scholar 

  14. Taal BG, Van Tinteren H, Zoetmulder FA; NACCP group. Adjuvant 5FU plus levamisole in colonic or rectal cancer: improved survival in stage II and III. Br J Cancer 2001; 85(10): 1437–43

    Article  PubMed  CAS  Google Scholar 

  15. Gordon AN, Fleagle JT, Guthrie D, et al. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol 2001; 19: 3312–22

    PubMed  CAS  Google Scholar 

  16. Porschen R, Bermann A, Loffler T, et al. Fluorouracil plus leucovorin as effective adjuvant chemotherapy in curatively resected stage III colon cancer: results of the trial adjCCa-01. J Clin Oncol 2001; 19: 1787–94

    PubMed  CAS  Google Scholar 

  17. List AF, Kopecky JK, Willman CL, et al. Benefit of cyclosporine modulation of drug resistance in patients with poor risk acute myeloid leukemia: a Southwest Oncology Group study. Blood 2001; 98: 3212–20

    Article  PubMed  CAS  Google Scholar 

  18. Kim TY, Yang SH, Lee SH, et al. A phase III randomized trial of combined chemoradiotherapy versus radiotherapy alone in locally advanced non-small-cell lung cancer. Am J clin Oncol 2002; 25(3): 238–43

    Article  PubMed  Google Scholar 

  19. Jassem J, Pienkowski T, Pluzanska A, et al. Doxorubicin and paclitaxel versus fluorouracil, doxorubicin and cyclophosphamide as first line therapy for women with metastatic breast cancer: final results of a randomized phase III muticenter trial. J Clin Oncol 2001; 19: 1707–15

    PubMed  CAS  Google Scholar 

  20. Jelic S, Stamatovic Lj, Vucicevic S, et al. Use of high-dose cytarabine to enhance cisplatin cytotoxicity effects on the response and overall survival rates of advanced head and neck cancer patients. Eur J Cancer 2002; 38: 1478–89

    Article  PubMed  CAS  Google Scholar 

  21. Slamon D, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001; 344: 783–92

    Article  PubMed  CAS  Google Scholar 

  22. Medical Research Council Oesophageal Cancer Working Party. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet 2002; 359: 1727–33

    Article  Google Scholar 

  23. Noda K, Nishiwaki Y, Kawahara M, et al. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small cell lung cancer. N Engl J Med 2002; 346: 85–91

    Article  PubMed  CAS  Google Scholar 

  24. Comella P. Phase III trial of cisplatin/gemcitabine with or without vinorelbine or paclitaxel in advanced non-small cell lung cancer. Semin Oncol 2001; 28: 7–10

    Article  PubMed  CAS  Google Scholar 

  25. O’Shaughnessy J, Miles D, Vukelia S, et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol 2002; 20: 2812–23

    Article  PubMed  Google Scholar 

  26. Gansauge F, Ramadani M, Pressmar J, et al. NSC-631570(Ukrain) in the palliative treatment of pancreatic cancer. Results of a phase II trial. Langenbeck’s Arch Surg 2002; 386: 570–4

    Article  Google Scholar 

  27. Frasci G, Lorusso V, Panza N, et al. Gemcitabine plus vinorelbine yields better survival outcome than vinorelbine alone in elderly patients with advanced non-small cell lung cancer. A Southern Italy Cooperative Oncology Group phase III trial. Lung Cancer 2001; 34 (Suppl. 4): S65–9

    Article  PubMed  Google Scholar 

  28. Saltz LB, Douillard JY, Pirotta N, et al. Irinotecan plus fluorouracil for metastatic colorectal cancer: a new survival standard. Oncologist 2001; 6: 81–91

    Article  PubMed  CAS  Google Scholar 

  29. Liu Yin JA, Wheatley K, Rees JK, Burnett AK; UK MRC Adult Leukemia Working Party. Comparison of ‘sequential’ versus ‘standard’ chemotherapy as re-induction treatment, with or without cyclosporine, in refractory/relapsed acute myeloid leukaemia (AML): results of the UK Medical Research Council AML-R trial. Br J Haematol 2001; 113(3): 713–26

    Article  PubMed  CAS  Google Scholar 

  30. Jelic S, Mitrovic L, Radosavljevic D, et al. Survival advantage for carboplatin substituting cisplatin in combination with vindesine and mitomycin C for stage IIIB and IV squamous-cell bronchogenic carcinoma: a randomized phase III study. Lung Cancer 2001; 34(1): 1–13

    Article  PubMed  CAS  Google Scholar 

  31. Pujol JL, Daure JP, Riviere A, et al. Etoposide plus cisplatin with or without the combination of 4-epidoxorubicin plus cyclophosphamide in treatment of extensive small cell lung cancer: a French federation of cancer institutes multicenter Phase III randomized trial. J Natl Cancer Inst 2001; 93: 300–8

    Article  PubMed  CAS  Google Scholar 

  32. Saarto T, Blomqvist C, Virkkunen P, Elomaa I. Adjuvant clodronate treatment does not reduce the frequency of skeletal metastases in node-positive breast cancer patients: 5-year results of a randomized controlled trial. J Clin Oncol 2001; 19(1): 10–7

    PubMed  CAS  Google Scholar 

  33. Bernard GR, Vincent JL, Laterre PF, et al. Recombinant human protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study group. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001; 344(10): 699–709

    Article  PubMed  CAS  Google Scholar 

  34. Manns BJ, Lee H, Doig CJ, Johnson D, Donaldson C. An economic evaluation of activated protein C treatment for severe sepsis. N Engl J Med 2002; 347(13): 993–1000

    Article  PubMed  Google Scholar 

  35. Hochman JS, Sleeper LA, White HD, et al. One-year survival following early revascularization for cardiogenic shock (SCHOCK trial). Indian Heart J 2001; 53(2): 240

    Google Scholar 

  36. Sibbald B. Making a case for a $2700-a-month drug. CMAJ 1999; 161(9): 1173

    PubMed  CAS  Google Scholar 

  37. Messori A, Santarlasci B, Trippoli S, Vaiani M. Controvalore economico del farmaco e beneficio clinico: stato dell’arte della metodologia e applicazione di un algoritmo farmacoeconomico. PharmacoEconomics-Italian Research Articles 2003; 5: 53–67

    Google Scholar 

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Messori, A., Santarlasci, B. & Trippoli, S. Guadagno di sopravvivenza dei nuovi farmaci. Pharmacoeconomics-Ital-Res-Articles 6, 95–104 (2004). https://doi.org/10.1007/BF03320627

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