Modeling the relationship between progression-free survival and overall survival: The phase II/III trial

Clinical Cancer Research

Volumn 19, Issue 10, 2013, Pages 2646-2656

  Redman, Mary W ^a   Goldman, Bryan H ^a   LeBlanc, Michael ^a   Schott, Anne ^b   Baker, Laurence H ^b  

^a Fred Hutchinson Cancer Research Center   (United States)

^b UNIVERSITY OF MICHIGAN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN; ETOPOSIDE;

ARTICLE; BREAST CANCER; CANCER PATIENT; CANCER SIZE; COLORECTAL CANCER; HEALTH CARE ORGANIZATION; HUMAN; KIDNEY CANCER; LEUKEMIA; LUNG SMALL CELL CANCER; LYMPHOMA; MESOTHELIOMA; MYELOMA; ONCOLOGY; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL (TOPIC); BIOASSAY; DISEASE COURSE; DISEASE FREE SURVIVAL; METHODOLOGY; NEOPLASMS; PATHOLOGY; PROCEDURES; REPRODUCIBILITY; THEORETICAL MODEL;

CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; ENDPOINT DETERMINATION; HUMANS; MODELS, THEORETICAL; NEOPLASMS; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN;

EID: 84878025917     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-12-2939     Document Type: Article

References (92)

1. Zhang JJ, Zhang L, Chen H, Murgo A, Dodd LE, Pazdur R, et al. Assessment of audit methodologies for bias evaluation of tumor progression in oncology clinical trials. Clin Cancer Res. 2013;19: 2637-45.
2. Redman M, Crowley J. Small randomized trials. J Thorac Oncol 2007;2:1-2.
3. Lara PN, Redman MW. The hazards of randomized phase II trials. Ann Oncol 2012;23:7-9.
4. Storer BA. Sequential phase II/III trial for binary outcomes. Stat Med 1990;9:229-35.
5. Inoue LYT, Thall PF, Berry DA. Seamlessly expanding a randomized phase II trial to phase III. Biometrics 2002;58:823-31.
6. Hunsberger S, Zhao Y, Simon R. A comparison of phase II study strategies. Clin Cancer Res 2009;15:5950-5.
7. Parmar MKB, Barthel FMS, Sydes M. Speeding up the evaluation of new agents in cancer. J Natl Cancer Inst 2008;100:1204-14.
8. Schaid DJ, Ingle JN, Wieand S, Ahmann DL. A design for phase II testing of anticancer agents within a phase III clinical trial. Control Clin Trials 1988;9:107-18.
9. Stallard N. Group-sequential methods for adaptive seamless phase II/III clinical trials. J Biopharm Stat 2011;21:787-801.
10. Todd S, Stallard N. A new clinical trial design combining phases II and III: sequential designs with treatment selection and a change of endpoint. Drug Inf J 2005;39:109-18.
11. Korn EL, Freidlin B, Abrams J, Halabi S. Design issues in randomized phase II/III trials. J Clin Oncol 2012;30:667-71.
12. Korn RL, Crowley JJ. Overview: progression-free survival as an endpoint in clinical trials with solid tumors. Clin Cancer Res 2013; 19:2607-12.
13. Villaruz LC, Socinski MA. The clinical viewpoint: definitions, limitations of RECIST, practical considerations of measurement. Clin Cancer Res 2013;19:2629-36.
14. Rubinstein LV, Korn EL, Freidlin B, Hunsberger S, Ivy SP, Smith MA. Design issues of randomized phase II trials and a proposal for phase II screening trials. J Clin Oncol 2005;23:199-206.
15. Ellenberg SS, Fleming TR, DeMets DL. Data monitoring committees in clinical trials: a practical perspective. New York: John Wiley and Sons; 2002.
16. Fleming TR, Sharples K, McCall J, Moore A, Rodgers A, Stewart R. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clinical Trials 2008;5:157-67.
17. Prentice RL. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989;8:431-40.
18. Goldman B, LeBlanc M, Crowley J. Interim futility analysis with intermediate endpoints. Clin Trials 2008;5:14-22.
19. Gandara DR, Lara PN Jr, Natale R, Belani C. Progress in small-cell lung cancer: the lowest common denominator. J Clin Oncol 2008; 26:4236-8.
20. Paridaens R, Biganzoli L, Bruning P, Klijn JG, Gamucci T, Houston S, et al. Paclitaxel versus doxorubicin as first-line single-agent chemotherapy for metastatic breast cancer: a European Organization for Research and Treatment of Cancer randomized study with cross-over. J Clin Oncol 2000;18:724-33.
21. Kaufman B, Mackey JR, Clemens MR, Bapsy PP, Vaid A, Wardley A, et al. Trastuzumab plus anastrozole versus anastrozole along for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: results from the randomized phase III TAnDEM study. J Clin Oncol 2009;27:5529-37.
22. Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, et al. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol 2009;27:5538-46.
23. Robert N, Leyland-Jones B, Asmar L, Belt R, Ilegbodu D, Loesch D, et al. Randomized phase III study of trastuzumab, paclitaxel and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer. J Clin Oncol 2006; 24:2786-92.
24. Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006;355:2733-43.
25. Cameron D, Casey M, Oliva C, Newstat B, Imwalle B, Geyer CE. Lapatinib plus capecitabine in women with HER-2-positive advanced breast cancer: final survival analysis of a phase III randomized trial. Oncologist 2010;15:924-34.
26. Blackwell KL, Burstein HJ, Storniolo AM, Rugo HS, Sledge G, Aktan G, et al. Randomized study of lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer. J Clin Oncol 2010;28:1124-30.
27. Di Leo A, Gomez HL, Aziz Z, Zvirbule Z, Bines J, Arbushites MC, et al. Phase III, double-blind, randomized study comparing lapatinib plus paclitaxel with placebo plus paclitaxel as first-line treatment for metastatic breast cancer. J Clin Oncol 2008;26:5544-52.
28. Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 2000;343:905-14.
29. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicenter randomized trial. Lancet 2000;355:1041-7.
30. de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 2000;18:2938-47.
31. Giacchetti S, Perpoint B, Zidani R, Le Bail N, Faggiuolo R, Focan C, et al. Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 2000;18:136-47.
32. Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, et al. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2004;22:23-30.
33. Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004;350:2335-42.
34. Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman DJ, et al. Wild-type KRAS is required for panitumumab efficacy in patients with metatstatic colorectal cancer. J Clin Oncol 2008;26:1626-34.
35. Van Cutsem E, Peeters M, Siena S, Humblet Y, Hendlisz A, Neyns B, et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 2007;25:1658-64.
36. Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, et al. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal. J Clin Oncol 2010;28:4706-13.
37. Douillard JY, Siena S, Cassidy J, Tabernero J, Burkes R, Barugel M, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol 2010; 28:4697-705.
38. Hecht JR, Mitchell E, Chidiac T, Scroggin C, Hagenstad C, Spigel D, et al. Arandomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol 2009;27:672-80.
39. Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009;360:1408-17.
40. Van Cutsem E, Lang I, Folprecht G, Nowacki M, Barone C, Shchepotin I, et al. Cetuximab plus FOLFIRI: final data from the CRYSTAL study on the association of KRAS and BRAF biomarker status with treatment outcome. J Clini Oncol 28:15s, 2010 (suppl; abstr 3570).
41. Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol 2010;28:1061-8.
42. Sternberg CN, Hawkins RE, Wagstaff J, Salman P, Mardiak J, Barrios CHC, et al. A randomized, double-blind phase III study (VEG105192) of pazopanib (paz) versus placebo (pbo) in patients with advanced/metastatic renal cell carcinoma (mRCC): updated safety results. J Clin Oncol 20, 2011 (suppl 7; abstr 313).
43. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27:3584-90.
44. Jonasch E, Corn P, Pagliaro LC, Warneke CL, Johnson MM, Tamboli P, et al. Upfront, randomized, phase 2 trial of sorafenib versus sorafenib and low-dose interferon alfa in patients with advanced renal cell carcinoma. Cancer 2010;116:57-65.
45. Escudier B, Szczylik C, Hutson TE, Demkow T, Staehler M, Rolland F, et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon alfa-2a in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27:1280-9.
46. Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007;356:125-34.
47. Escudier B, Bellmunt J, Négrier S, Bajetta E, Melichar B, Bracarda S, et al. Phase III trial of bevacizlumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival. J Clin Oncol 2010;28:2144-50.
48. Rini BI, Halabi S, Rosenberg JE, Stadler WM, Vaena DA, Archer L, et al. Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal carcinoma: final results of CALBG 90206. J Clin Oncol 2010;28:2137-43.
49. Rini BI, Halabi S, Rosenberg JE, Stadler WM, Vaena DA, Ou SS, et al. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol 2008;26:5422-8.
50. Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007;356:2271-81.
51. Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma. Cancer 2010;116:4256-65.
52. Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomized, openlabel, phase 3 trial. Lancet 2010;376:1164-74.
53. Hillmen P, Skotnicki AB, Robak T, Jaksic B, Dmoszynska A, Wu J, et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol 2007;25:5616-23.
54. Knauf WU, Lissitchkov T, Aldaoud A, Liberati AM, Loscertales J, Herbrecht R, et al. Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial. Br J Haematol 2012; 159:67-77.
55. Rai KR, Peterson BL, Appelbaum FR, Kolitz J, Elias L, Shepherd L, et al. Fludarabine compared with chlorombucil as primary therapy for chronic lymphocytic leukemia. N Engl J Med 2000;343:1750-7.
56. Wozniak AJ, Crowley JJ, Balcerzak SP, Weiss GR, Spiridonidis CH, Baker LH, et al. Randomized trial comparing cisplatin with cisplatin plus vinorelbine in the treatment of advanced non-small-cell lung cancer: a Southwest Oncology Group study. J Clin Oncol 1998;16: 2459-65.
57. Depierre A, Chastang C, Quoix E, Lebeau B, Blanchon F, Paillot N, et al. Vinorelbine versus vinorelbine plus cisplatin in advanced non-small cell lung cancer: a randomized trial. Ann Oncol 1994;5:37-42.
58. Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 2003;21:2636-44.
59. Cohen MH, Johnson JR, Chen Y-F, Sridhara R, Pazdur R. FDA drug approval summary: erlotinib (Tarceva) tablets. Oncologist 2005;15: 1344-51.
60. Inoue A, Kobayashi K, Maemondo M, Sugawara S, Oizumi S, Isobe H, et al. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol 2013;24:54-9.
61. Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, et al. Gefitinib or chemotherapy for non-small-cell lung cancer and mutated EGRF. N Engl J Med 2010;362:2380-8.
62. Herbst RS, Giaccone G, Schiller JH, Natale RB, Miller V, Manegold C, et al. Gefitinib in combination with paclitaxel and carboplatin in advanced non-small cell lung cancer: a phase III trial-INTACT 2. J Clin Oncol 2004;22:785-94.
63. Giaccone G, Herbst RS, Manegold C, Scagliotti G, Rosell R, Miller V, et al. Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 1. J Clin Oncol 2004;22:777-84.
64. Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomized phase III trial. Lancet 2008;372:1809-18.
65. Mitsudomi T, Morita S, Yatabe Y, Negoro S, Okamoto I, Tsurutani J, et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomized phase 3 trial. Lancet Oncol 2010;11:121-8.
66. Fisher RI, LeBlanc M, Press OW, Maloney DG, Unger JM, Miller TP. New treatment options have changed the survival of patients with follicular lymphoma. J Clin Oncol 2005;23:8447-52.
67. Richardson PG, Sonneveld P, Schuster M, Irwin D, Stadtmauer E, Facon T, et al. Extended follow-up of a phase 3 trial in relapsed multiple myeloma: final time-to-event results of the APEX trial. Blood 2007; 110:3557-60.
68. Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, et al. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med 2007;357:2133-42.
69. Orlowski RZ, Nagler A, Sonneveld P, Bladé J, Hajek R, Spencer A, et al. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol 2007;25:3892-901.
70. Gay F, Hayman SR, Lacy MQ, Buadi F, Gertz MA, Kumar S, et al. Lenalidomide plus dexamethasone versus thalidomide plus dexamethasone in newly diagnosed multiple myeloma: a comparative analysis of 411 patients. Blood 2010;115:1343-50.
71. Gay F, Hayman S, Lacy MQ, Buadi F, Gertz MA, Kumar S, et al. Superiority of lenalidomide-dexamethasone versus thalidomide-dexamethasone as initial therapy for newly diagnosed multiple myeloma. Blood (ASH Annual Meeting Abstracts) 2009;114:Abstract 3884.
72. Kapoor P, Rajkumar SV, Dispenzieri A, Gertz MA, Lacy MQ, Dingli D, et al. Melphalan and prednisone versus melphalan, prednisone and thalidomide for elderly and/or transplant ineligible patients with multiple myeloma: a meta-analysis. Leukemia 2011;25:689-96.
73. Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004;351:1513-20.
74. de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomized open-label trial. Lancet 2010;376:1147-54.
75. Barlogie B, Kyle RA, Anderson KC, Greipp PR, Lazarus HM, Hurd DD, et al. Standard chemotherapy compared with high-dose chemoradiotherapy for multiple myeloma: final results of phase IIIUS Intergroup Trial S9321. J Clin Oncol 2006;24:929-36.
76. Kelly K, Crowley J, Bunn PA Jr, Presant CA, Grevstad PK, Moinpour CM, et al. Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a Southwest Oncology Group trial. J Clin Oncol 2001;19:3210-8.
77. Kelly K, Chansky K, Gaspar LE, Albain KS, Jett J, Ung YC, et al. Phase III trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel consolidation in inoperable stage III non-small-cell lung cancer: SWOG S0023. J Clin Oncol 2008;26:2450-6.
78. Lara PN Jr, Natale R, Crowley J, Lenz HJ, Redman MW, Carleton JE, et al. Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive-stage small-cell lung cancer: clinical and pharmacogenomic results from SWOG S0124. J Clin Oncol 2009; 27:2530-5.
79. Leichman CG, Benedetti JK, Zalupski MM, Hochster H, Shields AF, Lenz HJ, et al. Assessment of infusional 5-fluorouracil schedule and dose intensity: a Southwest Oncology Group and Eastern Cooperative Oncology Group study. Clin Colorectal Cancer 2005;5:119-23.
80. Linden HM, Haskell CM, Green SJ, Osborne CK, Sledge GW Jr, Shapiro CL, et al. Sequenced compared with simultaneous anthracycline and cyclophosphamide in high-risk stage I and II breast cancer: final analysis from INT-0137 (S9313). J Clin Oncol 2007;25:656-61.
81. Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, et al. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med 2001;345:725-30.
82. Peters WA III, Liu PY, Barrett RJ II, Stock RJ, Monk BJ, Berek JS, et al. Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol 2000;18: 1606-13.
83. Philip PA, Benedetti J, Corless CL, Wong R, O'Reilly EM, Flynn PJ, et al. Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in patients with advanced pancreatic adenocarcinoma: Southwest Oncology Group-directed intergroup trial S0205. J Clin Oncol 2010;28:3605-10.
84. Poplin EA, Benedetti JK, Estes NC, Haller DG, Mayer RJ, Goldberg RM, et al. Phase III Southwest Oncology Group 9415/Intergroup 0153 randomized trial of fluorouracil, leucovorin, and levamisole versus fluorouracil continuous infusion and levamisole for adjuvant treatment of stage III and high-risk stage II colon cancer. J Clin Oncol 2005; 23:1819-25.
85. Thompson JA, Fisher RI, Leblanc M, Forman SJ, Press OW, Unger JM, et al. Total body irradiation, etoposide, cyclophosphamide, and autologous peripheral blood stem-cell transplantation followed by randomization to therapy with interleukin-2 versus observation for patients with non-Hodgkin lymphoma: results of a phase 3 randomized trial by the Southwest Oncology Group (SWOG 9438). Blood 2008;111:4048-54.
86. Williamson SK, Crowley JJ, Lara PN Jr, McCoy J, Lau DH, Tucker RW, et al. Phase III trial of paclitaxel plus carboplatin with or without tirapazamine in advanced non-small-cell lung cancer: Southwest Oncology Group Trial S0003. J Clin Oncol 2005;23:9097-104
87. Buyse M, Burzykowski T, Carroll K, Michiels S, Sargent DJ, Miller LL, et al. Progression-free survival is a surrogate for survival in advanced colorectal cancer (2007) J Clin Oncol 2007;25:5218-24.
88. Broglio KR, Berry DA. Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst 2009;101: 1642-9.
89. Fleming TR, Rothmann MD, Lu HL. Issues in using progression-free survival when evaluating oncology products. J Clin Oncol 2009;27: 2874-80.
90. Saad ED, Katz A, Hoff PM, Buyse M. Progression-free survival as surrogate and as true end point: insights from the breast and colorectal cancer literature. Ann Oncol 2010;21:7-12.
91. Oza AM, Castonguay V, Tsoref D, Diaz-Padilla I, Karakasis K, Mackay H, et al. Progression-free survival in advanced ovarian cancer: a Canadian review and expert panel perspective. Curr Oncol 2011;18 (Suppl 2):S20-7.
92. Hotta K, Suzuki E, Di Maio M, Chiodini P, Fujiwara Y, Takigawa N, et al. Progression-free survival and overall survival in phase III trials of molecular-targeted agents in advanced non-small-cell lung cancer. Lung Cancer 2013;79:20-6.