Clinical genitourinary cancer · 2026
Outcomes of Complete Responders From First-line Therapy in Metastatic Renal Cell Carcinoma in the Real World: An Analysis From the International Metastatic Renal Cell Carcinoma Database Consortium.
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Zarba Martin, Maj David, Chehade Razane El Hajj, Semaan Karl, Wells John Connor, Donskov Frede, McKay Rana R, Sade Juan Pablo, Takemura Kosuke, Wood Lori A, Davis Ian D, Vaishampayan Ulka, Basterretxea Laura, Porta Camillo, Suarez Cristina, de Velasco Guillermo, Moradi Ali, Choueiri Toni K, Heng Daniel Y C
Аннотация
INTRODUCTION: Patients with mRCC who achieve a complete response (CR) to immuno-oncology (IO) combinations have an excellent prognosis and may experience prolonged responses. However, real-world data on CR durability, mortality, and need for subsequent therapy remain limited.
PATIENTS AND METHODS: Using the International mRCC Database Consortium (IMDC), we identified patients with mRCC who achieved a documented CR to first-line treatment between 2015 and 2022. We described baseline characteristics, time to next treatment (TTNT), time to second line (TT2L), overall survival (OS), and use of subsequent therapies in patients treated with a vascular endotelial growth factor receptor pathway targeted therapy vascular endotelial growth factor (VEGF), IO plus VEGF (IO-VE), or Ipilimumab plus Nivolumab (IOIO).
RESULTS: CR was achieved with IO-VE in 25 of 610 (4.1%) patients, with IO-IO in 82 of 1313 (6.2%), and with VEGF in 46 of 2980 (1.5%) patients. OS in patients with CRs was not significantly different (log-rank P = .42) among the 3 treatment groups. After a median follow-up of 46.7 months, 4-year OS was for IO-VE 100% (95% CI, 100%-100%; HR ref), for IO-IO 92.9% (95% CI, 86.2%-100%; HR 1.89, 95% CI, 0.22-16.4), and for VEGF 94.8% (95% CI 88%-100%; HR 3.18, 95% CI 0.4-25.2). In the IO-VE cohort, 5 (20%) started second-line therapy, and 1 died; in IO-IO, 11 (13.4%) began second-line, and 5 (6.1%) died; and in VEGF, 17 (37%) started second-line, and 9 (19.6%) died. TTNT was not reached for any treatment, and TT2L was in IO-VE 46.8 months (95% CI, 27.5-NR), in IO-IO 30.2 months (95% CI, 21.5-NR), and in VEGF 23 months (95% CI, 14.3-51.7) (P = .66). IO rechallenge occurred in 20% (n = 1) of IO-VE and 63.6% (n = 7) of IO-IO patients receiving second-line, with CR to second-line in 2/8, PR in 4/8, standard deviation in 2/8, and no deaths.
DISCUSSION: This real-world study confirms that achieving CR confers an excellent prognosis. However, CR does not guarantee a cure, as a subset of patients do experience a relapse. Retreatment with IO was frequent and effective. These results support the significance of CR but highlight the need for ongoing surveillance and tailored care.
PATIENTS AND METHODS: Using the International mRCC Database Consortium (IMDC), we identified patients with mRCC who achieved a documented CR to first-line treatment between 2015 and 2022. We described baseline characteristics, time to next treatment (TTNT), time to second line (TT2L), overall survival (OS), and use of subsequent therapies in patients treated with a vascular endotelial growth factor receptor pathway targeted therapy vascular endotelial growth factor (VEGF), IO plus VEGF (IO-VE), or Ipilimumab plus Nivolumab (IOIO).
RESULTS: CR was achieved with IO-VE in 25 of 610 (4.1%) patients, with IO-IO in 82 of 1313 (6.2%), and with VEGF in 46 of 2980 (1.5%) patients. OS in patients with CRs was not significantly different (log-rank P = .42) among the 3 treatment groups. After a median follow-up of 46.7 months, 4-year OS was for IO-VE 100% (95% CI, 100%-100%; HR ref), for IO-IO 92.9% (95% CI, 86.2%-100%; HR 1.89, 95% CI, 0.22-16.4), and for VEGF 94.8% (95% CI 88%-100%; HR 3.18, 95% CI 0.4-25.2). In the IO-VE cohort, 5 (20%) started second-line therapy, and 1 died; in IO-IO, 11 (13.4%) began second-line, and 5 (6.1%) died; and in VEGF, 17 (37%) started second-line, and 9 (19.6%) died. TTNT was not reached for any treatment, and TT2L was in IO-VE 46.8 months (95% CI, 27.5-NR), in IO-IO 30.2 months (95% CI, 21.5-NR), and in VEGF 23 months (95% CI, 14.3-51.7) (P = .66). IO rechallenge occurred in 20% (n = 1) of IO-VE and 63.6% (n = 7) of IO-IO patients receiving second-line, with CR to second-line in 2/8, PR in 4/8, standard deviation in 2/8, and no deaths.
DISCUSSION: This real-world study confirms that achieving CR confers an excellent prognosis. However, CR does not guarantee a cure, as a subset of patients do experience a relapse. Retreatment with IO was frequent and effective. These results support the significance of CR but highlight the need for ongoing surveillance and tailored care.