OBJECTIVE: To study the impact of the prognostic factors liver metastasis (LM), anaemia (haemoglobin [Hb] <10 g/dL), Eastern Cooperative Oncology Group performance status (ECOG-PS) ≥1 and time from previous chemotherapy (TFPC) on the activity of second-line therapy for advanced urothelial carcinoma (UC). PATIENTS AND METHODS: Twelve phase II trials evaluating second-line chemotherapy and/or biological characteristics (n = 748) in patients with progressive disease were pooled. Progression-free survival (PFS) was defined as tumour progression or death from any cause. The PFS rate at 6 months (PFS6) was defined from the date of registration and calculated using the Kaplan-Meier method. Response rate (RR) was defined using Response Evaluation Criteria in Solid Tumours (RECIST) 1.0. A nomogram predicting PFS6 was constructed using the rms software package in R (http://www.r-project.org). RESULTS: Data regarding progression, anaemia, LM, ECOG-PS and TFPC were available from 570 patients in nine phase II trials. The overall median PFS was 2.7 months, PFS6 was 22.2% (95% confidence interval 18.8-25.9) and the RR was 17.5% (95% CI: 14.5-20.9%). For every unit increase in risk group, the hazard of progression in 6 months increased by 41% and the odds of response decreased by 48%. A nomogram was constructed to predict PFS6 on an individual patient level. The model was internally validated and was shown to have acceptable calibration performance. CONCLUSIONS: The RR and PFS6 vary as a function of baseline prognostic factors in patients receiving second-line therapy for advanced UC. A nomogram incorporating prognostic factors facilitates the evaluation of outcomes across phase II trials enrolling heterogeneous populations and helps select suitable agents for phase III testing.
OBJECTIVE: To study the impact of the prognostic factors liver metastasis (LM), anaemia (haemoglobin [Hb] <10 g/dL), Eastern Cooperative Oncology Group performance status (ECOG-PS) ≥1 and time from previous chemotherapy (TFPC) on the activity of second-line therapy for advanced urothelial carcinoma (UC). PATIENTS AND METHODS: Twelve phase II trials evaluating second-line chemotherapy and/or biological characteristics (n = 748) in patients with progressive disease were pooled. Progression-free survival (PFS) was defined as tumour progression or death from any cause. The PFS rate at 6 months (PFS6) was defined from the date of registration and calculated using the Kaplan-Meier method. Response rate (RR) was defined using Response Evaluation Criteria in Solid Tumours (RECIST) 1.0. A nomogram predicting PFS6 was constructed using the rms software package in R (http://www.r-project.org). RESULTS: Data regarding progression, anaemia, LM, ECOG-PS and TFPC were available from 570 patients in nine phase II trials. The overall median PFS was 2.7 months, PFS6 was 22.2% (95% confidence interval 18.8-25.9) and the RR was 17.5% (95% CI: 14.5-20.9%). For every unit increase in risk group, the hazard of progression in 6 months increased by 41% and the odds of response decreased by 48%. A nomogram was constructed to predict PFS6 on an individual patient level. The model was internally validated and was shown to have acceptable calibration performance. CONCLUSIONS: The RR and PFS6 vary as a function of baseline prognostic factors in patients receiving second-line therapy for advanced UC. A nomogram incorporating prognostic factors facilitates the evaluation of outcomes across phase II trials enrolling heterogeneous populations and helps select suitable agents for phase III testing.
Authors: Richard M Bambury; David J Benjamin; Joshua L Chaim; Emily C Zabor; John Sullivan; Ilana R Garcia-Grossman; Ashley M Regazzi; Irina Ostrovnaya; Aryln Apollo; Han Xiao; Martin H Voss; Gopa Iyer; Dean F Bajorin; Jonathan E Rosenberg Journal: Oncologist Date: 2015-04-06
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Authors: Ali Raza Khaki; Ang Li; Leonidas N Diamantopoulos; Natalie J Miller; Lucia Carril-Ajuria; Daniel Castellano; Ivan De Kouchkovsky; Vadim Koshkin; Joseph Park; Ajjai Alva; Mehmet A Bilen; Tyler Stewart; Victor Santos; Neeraj Agarwal; Jayanshu Jain; Yousef Zakharia; Rafael Morales-Barrera; Michael Devitt; Ariel Nelson; Christopher J Hoimes; Evan Shreck; Benjamin A Gartrell; Alex Sankin; Abhishek Tripathi; Roubini Zakopoulou; Aristotelis Bamias; Alejo Rodriguez-Vida; Alexandra Drakaki; Sandy Liu; Vivek Kumar; Mark P Lythgoe; David J Pinato; Jure Murgic; Ana Fröbe; Monika Joshi; Pedro Isaacsson Velho; Noah Hahn; Lucia Alonso Buznego; Ignacio Duran; Marcus Moses; Pedro Barata; Matthew D Galsky; Guru Sonpavde; Evan Y Yu; Veena Shankaran; Gary H Lyman; Petros Grivas Journal: Eur Urol Oncol Date: 2021-01-07
Authors: Karin Holmsten; Line Dohn; Niels Viggo Jensen; Carl-Henrik Shah; Fredrik Jäderling; Helle Pappot; Anders Ullén Journal: Oncol Lett Date: 2016-06-23 Impact factor: 2.967