scholarly journals Clinical outcomes in patients with metastatic renal cell carcinoma and brain metastasis treated with ipilimumab and nivolumab

2021 ◽  
Vol 9 (9) ◽  
pp. e003281
Author(s):  
Landon C. Brown ◽  
Kunal Desai ◽  
Wei Wei ◽  
Emily N. Kinsey ◽  
Chester Kao ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Brain Metastasis ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Objective Response ◽  
Cleveland Clinic ◽  
Local Therapy ◽  
Radiographic Response ◽  
Poor Risk

The combination of ipilimumab plus nivolumab (I+N) has greatly improved outcomes in patients with intermediate or poor-risk untreated metastatic renal cell carcinoma (mRCC). However, little is known about the outcomes of patients with brain metastasis (BrM) treated with I+N. A search was performed to retrospectively identify all patients with mRCC treated with I+N in the Duke Cancer Institute and the Cleveland Clinic Taussig Cancer Center, followed by a chart review. Patients were included if they had BrM at the time of I+N initiation. Cohort characteristics are summarized with descriptive statistics. Kaplan-Meier method was used to estimate overall survival (OS) and global, intracranial, and extracranial progression-free survival (PFS) for the cohort and log rank test was used to compare OS and PFS between patient groups. Radiographic response was categorized by RECIST. Fisher’s exact test was used to correlate patient factors with radiographic response. From October 2017 to December 2020, 19 patients with BrM received I+N for mRCC with a median follow-up time of 27.1 months (range 15.0–35.6). By International Metastatic RCC Database Consortium (IMDC) risk criteria, 16% had favorable, 58% had intermediate, and 26% had poor-risk disease. 68% were systemic therapy naïve, and 77% of patients had clear cell histology. 95% had received local CNS directed therapy with surgery, radiotherapy, or both. The objective response rate was 44% (0% complete response) with three of six patients treated in the second line or greater setting experiencing a partial response. The median PFS was 7.6 months (95% CI 5.6 to 14.9). The median extracranial PFS was 8.5 months (95% CI 5.6 to 19.7), and median intracranial PFS was 14.7 months (95% CI 7.2 to not reached). No variables assessed were significantly associated with radiographic response (gender, IMDC risk, presence of bone metastasis, line of therapy, or presence of immune related adverse events). In our retrospective cohort of patients with mRCC with BrM, I+N, in combination with CNS-directed local therapy, appears to have clinical efficacy as previously described with responses seen beyond the first-line setting. Further investigation is warranted in this population given exclusion from prior clinical trials.

An alternative titration schedule of axitinib in metastatic renal cell carcinoma.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 444-444 ◽  
Author(s):  
Vyshak Alva Venur ◽  
Laura S. Wood ◽  
Paul Elson ◽  
Allison Martin ◽  
Jennifer Beach ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Median Time ◽  
Metastatic Renal Cell Carcinoma ◽  
Dose Escalation ◽  
Renal Cell ◽  
Objective Response ◽  
Dose Titration ◽  
Radiographic Response ◽  
A Prospective Study

444 Background: Titration of axitinib for metastatic renal cell carcinoma (mRCC) is currently based on tolerance with escalation from 10 mg/day to 14 mg/day and then to 20 mg/day. However, not all patients who can be titrated upward require a higher dose for response, nor do all patients tolerate the increased dose levels. An alternative titrating strategy was employed based on radiographic response, tolerance, and using intermediate dosing levels. Methods: In this retrospective analysis of mRCC, axitinib was initiated at 10 mg/day (5 mg BID). Response was assessed with CT scans at 6 weeks after each dosing change. Patients with response by MASS criteria and acceptable toxicity (<grade 2) were continued on the same dose. If the patient had no response and <grade 2 toxicity, axitinib was increased by 2 mg/day at each reassessment (e.g., initially to 6 mg BID), to a maximum of 20 mg/day. If the patient had >grade 2 toxicity the dose was reduced by 1 mg/day. Results: Twenty-eight patients were started on axitinib as per the above titration scheme between May 2013 and June 2014. Twenty four patients had clear cell, 3 had papillary and 1 had chromophobe mRCC, and all patients had received at least one prior systemic therapy. The final dose of axitinib ranged from 2 mg/day through 20 mg/day. Eleven patients did not change from the starting dose. Ten patients (36%) underwent dose escalation whereas 7 patients required dose reduction. Overall, for the 17 patients who had their dosage adjusted, the median time to final (current) dose was 9.9 weeks (range, 6.0-23.7), and the median time within a dose was 6.6 weeks (range, 1.1-10.0). Five of 10 patients who required dose escalation ended up on doses other than 14 mg/day or 20 mg/day (three at 12 mg/day and two at 16 mg/day). Among the dose-escalated patients, two patients had grade 1 diarrhea, one each had grade 3 diarrhea, grade 2 diarrhea, grade 1 nausea, grade 2 fatigue, grade 1 hypertension and grade 1 hand foot syndrome. The objective response rate was 17% with a median PFS of 7.4 months. Conclusions: Axitinib dose titration guided by radiographic response and toxicity is a feasible strategy with acceptable overall disease control and good tolerance. A prospective study is warranted.

Multicenter retrospective analysis of patients with metastatic renal cell carcinoma (mRCC) and bone metastases treated with ipilimumab and nivolumab.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 648-648
Author(s):  
Kunal Desai ◽  
Landon Carter Brown ◽  
Wei Wei ◽  
Kimberly D. Allman ◽  
Allison Martin ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Adverse Events ◽  
Bone Metastases ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Objective Response ◽  
Cleveland Clinic ◽  
Clinical Activity ◽  
Best Response

648 Background: Ipilimumab & nivolumab (I+N) followed by nivolumab maintenance is approved as front-line therapy for intermediate and poor-risk metastatic renal cell carcinoma (mRCC). Bone metastases (BM) are present in up to 30% of mRCC patients (pts) and remain a clinical challenge. We present a multicenter experience of mRCC pts with BMs treated with I+N. Methods: Patients with mRCC and bone metastases treated with (I+N) at Duke Cancer Network and Cleveland Clinic were retrospectively reviewed. Patient demographics, tumor histology, IMDC risk stratification, RECIST-defined ORR and adverse events were collected. Fisher’s exact test was used to determine predictors of response (alpha 0.05). Results: Forty-eight pts with mRCC and radiographically confirmed BMs were included in the analysis: 81% male; median age 54 (range: 41-81); 77% clear cell histology; IMDC risk 17%/52%/31% favorable/intermediate/poor, respectively. I+N was used as first-line medical therapy in 63% of pts and ≥ second-line in remaining pts. Best response on I+N per RECIST criteria: objective response rate (ORR) 23% (0% CR); 23% stable disease (SD); 44% progressive disease (PD). Median duration of treatment was 64 days with 27% of pts still on I+N. PD was the most common reason for discontinuation (38%) followed by adverse events (19%). Nearly half of pts (48%) experienced at least one irAE attributed to I+N therapy. None of the factors examined above was significantly associated with response to treatment. Conclusions: I+N has clinical activity and is well tolerated in mRCC pts with bone metastases; however ORR in this population is lower than expected and 44% pts had PD as best response. Therefore, identifying prognostic factors & improving novel therapies for this cohort of patients are priorities, given overall poorer outcomes in this population.

Sunitinib versus sorafenib as first-line therapy for patients with metastatic renal cell carcinoma with favorable or intermediate MSKCC risk factors: A multicenter randomized trial, CROSS-J-RCC.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 502-502 ◽  
Author(s):  
Yoshihiko Tomita ◽  
Sei Naito ◽  
Naoto Sassa ◽  
Atsushi Takahashi ◽  
Tsunenori Kondo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Brain Metastasis ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Objective Response ◽  
Phase Iii ◽  
First Line ◽  
Primary Tumors

502 Background: Sorafenib (SO), an earlier introduced kinase inhibitor, and sunitinib (SU), a standard first-line treatment drug for metastatic renal cell carcinoma (mRCC), were associated with progression-free survival (PFS) of 5.7 and 11 months (M) in independent clinical trials, respectively. We compared PFS of first-line SU and SO in a multicenter, randomized, open-label, phase III trial. Methods: Patients with untreated, measurable (by RECIST v1.1) clear-cell mRCC stratified according to MSKCC risk criteria, nephrectomy, and institution were randomized in 1:1 to receive SU (50 mg qd 4 wks on-2 wks off) or SO (400 mg bid). The calculated sample size was 59/group for α = 0.05, β = 0.10, and a censoring rate of 15%. Results: Of 124 enrolled patients, from Feb. 2010 to Jul. 2012, from 39 institutions, 120 were evaluable (SU, 57 and SO, 63). Patient baseline characteristics in the SU vs SO groups were as follows: favorable risk, 21% vs 22%; presence of stable brain metastasis, 8.8% vs 1.6% and with nephrectomy, 88% vs 89%. Median PFS (mPFS) was 8.7 and 7.0 M in the SU and SO groups, respectively (hazard ratio [HR] 0.67, 95% confidence interval [CI] 0.42–1.08; p= 0.095). mPFS was 31.2 and 6.2 M (HR 0.27, 95%CI 0.08–0.90; p = 0.023) in the favorable risk group, 11.9 and 6.5 M (HR 0.31, 95%CI 0.14–0.69; p = 0.035) in patients with T1 or T2 primary tumors, and 11.6 and 7.0 M (HR 0.41, 95%CI 0.36–0.98; p = 0.038) in those without brain metastasis, in the SU and SO groups, respectively. Objective response rates for SU group was 35.3%; SO was 27.8% (p = 0.407). Overall survival was not reached. The most common adverse events (all grade, all cause) were hand-foot syndrome (SU vs SO, 71% vs 86%), hypothyroidism (70% vs 33%), fatigue (57% vs 40%), hypertension (55% vs 44%) and diarrhea (23% vs 38%). Conclusions: The primary endpoint was not achieved, but SU tended to be associated with longer mPFS in all cases. In patients with favorable risk, T1 or T2 primary tumors or in those without brain metastasis, significantly longer mPFS were noticed. Brain metastasis was associated with poorer prognosis even if it was stable at baseline. Clinical trial number: NCT01481870. Clinical trial information: 01481870.

scholarly journals Efficacy and Safety of Nivolumab and Ipilimumab for Advanced or Metastatic Renal Cell Carcinoma: A Multicenter Retrospective Cohort Study

2021 ◽  
Vol 28 (2) ◽  
pp. 1402-1411
Author(s):  
Koji Iinuma ◽  
Koji Kameyama ◽  
Kei Kawada ◽  
Shota Fujimoto ◽  
Kimiaki Takagi ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Objective Response ◽  
Predictive Biomarkers ◽  
Progression Free Survival ◽  
Predictive Marker ◽  
Efficacy And Safety ◽  
Lymphocyte Ratio

We conducted a multicenter, retrospective study to evaluate the efficacy and safety of combination nivolumab plus ipilimumab (NIVO+IPI) in 35 patients with advanced or metastatic renal cell carcinoma (mRCC). In this study, we focused on patients who received NIVO+IPI and were stratified into intermediate- or poor-risk disease according to the International Metastatic Renal Cell Carcinoma Database Consortium model at five institutions in Japan. The primary endpoint was overall survival (OS). Secondary endpoints were disease control rate (DCR), best overall response (BOR), objective response rate (ORR), and progression-free survival (PFS). In addition, we evaluated the role of inflammatory cell ratios, namely neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), as predictive biomarkers in patients with mRCC. The median follow-up period was 1 year, and the 1-year OS rate was 95.8%. The ORR and DCR were 34.3% and 80.0%, respectively. According to BOR, four patients (11.4%) achieved complete response. According to NLR stratification, the 1-year PFS rates were 82.6% and 23.7% when the NLR was ≤4.6 and >4.6, respectively (p = 0.04). Based on PLR stratification, the 1-year PFS rates were 81.7% and 34.3% when the PLR was ≤188.1 and >188.1, respectively (p = 0.033). Although 71.4% of the patients experienced treatment-related adverse events (TRAEs) with NIVO+IPI, only four patients discontinued NIVO+IPI due to grade 3/4 TRAEs. Patients treated with NIVO+IPI as a first-line therapy for advanced or mRCC achieved relatively better oncological outcomes. Therefore, NIVO+IPI may have potential advantages and may lead to a treatment effect compared to those receiving targeted therapies. In addition, PLR >188.1 may be a useful predictive marker for mRCC patients who received NIVO+IPI.

Objective response and time to progression on sequential treatment with sunitinib and sorafenib in metastatic renal cell carcinoma

2012 ◽  
Vol 29 (5) ◽  
pp. 3321-3324 ◽  
Author(s):  
Tomas Buchler ◽  
Tomas Pavlik ◽  
Zbynek Bortlicek ◽  
Alexandr Poprach ◽  
Rostislav Vyzula ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Objective Response ◽  
Sequential Treatment ◽  
Time To Progression

scholarly journals Association of baseline neutrophil-to-eosinophil ratio with response to nivolumab plus ipilimumab in patients with metastatic renal cell carcinoma

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Matthew D. Tucker ◽  
Landon C. Brown ◽  
Yu-Wei Chen ◽  
Chester Kao ◽  
Nathan Hirshman ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Complete Blood Count ◽  
Objective Response ◽  
Progression Free Survival ◽  
Cancer Center ◽  
Median Baseline ◽  
Treatment Naïve

Abstract Background The identification of biomarkers to select patients with metastatic renal cell carcinoma (mRCC) most likely to respond to combination immunotherapy (IO) is needed. We sought to investigate an association of the baseline neutrophil-to-eosinophil ratio (NER) with outcomes to nivolumab plus ipilimumab for patients with mRCC. Methods We performed a retrospective review of patients with clear cell mRCC treated with nivolumab plus ipilimumab from Vanderbilt-Ingram Cancer Center and Duke Cancer Institute. Patients with prior receipt of immunotherapy and those without available baseline complete blood count with differential were excluded. Patients were divided into groups by the median baseline NER and analyzed for overall survival (OS), progression free survival (PFS), and objective response rate (ORR). Patients were also divided by median baseline neutrophil-to-lymphocyte ratio (NLR) and analyzed for clinical outcome. Further analyses of patients above/below the median NER and NLR were performed in subgroups of IMDC intermediate/poor risk, IMDC favorable risk, and treatment naïve patients. Results A total of 110 patients were included: median age was 61 years and 75% were treatment naïve. The median NER (mNER) at baseline was 26.4. The ORR was 40% for patients with <mNER compared to 21.8% among patients with >mNER (OR 2.39, p = 0.04). The median PFS for patients with <mNER was significantly longer at 8.6 months (mo) compared to 3.2 mo for patients with >mNER (HR 0.50, p < 0.01). Median OS was not reached (NR) for patients with <mNER compared with 27.3 mo for patients with >mNER (HR 0.31, p < 0.01). The median NLR (mNLR) was 3.42. While patients with <mNLR showed improvement in OS (HR 0.42, p = 0.02), PFS and ORR did not differ compared with patients in the >mNLR group. Conclusions A lower baseline NER was associated with improved clinical outcomes (PFS, OS, and ORR) in patients with mRCC treated with nivolumab plus ipilimumab, and prospective validation of the baseline NER as a predictive biomarker for response to immunotherapy-based combinations in mRCC is warranted.

Efficacy of nivolumab/ipilimumab in patients with initial or late progression with nivolumab: Updated analysis of a tailored approach in advanced renal cell carcinoma (TITAN-RCC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4576-4576
Author(s):  
Marc-Oliver Grimm ◽  
Emilio Esteban ◽  
Philippe Barthélémy ◽  
Manuela Schmidinger ◽  
Jonas Busch ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Remission Rate ◽  
Objective Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Poor Risk ◽  
Secondary Endpoints ◽  
Tailored Approach

4576 Background: TITAN-RCC uses a tailored immunotherapy approach in renal cell carcinoma (RCC), starting with nivolumab (nivo) induction followed by nivo + ipilimumab (ipi) as immunotherapeutic “boost” in non-responders. Patients with initial partial or complete response (PR/CR) continued with nivo maintenance but received later “boosts” for progressive disease (PD). Here we report updated results focusing on the efficacy of nivo+ipi in patients with initial PD vs. initial responders with later PD. Methods: Patients with IMDC intermediate and poor risk advanced clear cell RCC were recruited between OCT 2016 and DEC 2018. Patients started with nivo 240 mg Q2W induction. Patients with early significant PD (week 8) or non-responders at week 16 received 2-4 nivo+ipi “boost” cycles. Responders (PR/CR) to nivo monotherapy continued with maintenance but could receive nivo+ipi for later PD. The primary endpoint is confirmed investigator assessed objective response rate (ORR) per RECIST in first line (1L) and second line (2L). Secondary endpoints included activity of nivo monotherapy, remission rate with nivo+ipi “boost”, safety and overall survival (OS). Results: 109 1L and 98 2L (after TKI) patients were analyzed for efficacy. Median age was 65 years (range 20-87). 71 % were intermediate and 25 % poor risk. Confirmed ORR with nivo monotherapy was 28 % for 1L and 17 % for 2L. After a median follow-up of 12.8 months best overall response after nivo induction ± nivo+ipi was 36 % in 1L and 30 % in 2L. Of all patients, 38 received nivo+ipi for stable disease (SD) up to week 16, with 1 (3 %), 4 (11 %) and 26 (68 %) achieving CR, PR and SD, respectively. 28 patients in 1L and 43 in 2L were boosted with nivo+ipi for initial PD. Of these, 3 (11 %) and 8 (29 %) achieved PR and SD, respectively, in 1L, whereas 3 (7.0 %) achieved CR, 6 (14 %) PR and 13 (30 %) SD in 2L. 16 and 10 patients received “boosts” later than week 16 for PD during nivo maintenance in 1L and 2L, respectively. Thereof, 3 (19 %) achieved PR and 5 (31 %) SD in 1L, whereas 2 (20 %) achieved PR and 3 (30 %) SD in 2L. Progression-free survival was 6.3 months (95 % CI 3.7 – 10.1) and 3.7 months (95 % CI 2.0 - 4.5) in 1L and 2L, respectively. OS was 27.2 months (95 % CI 19.9 – not estimable (NE)) in 1L and 20.2 months (95 % CI 15.6 – NE) in 2L. Treatment-related adverse events will be presented. Conclusions: Our tailored approach with nivo+ipi “boosts” results in improved response rates compared to nivo monotherapy. Our updated analysis suggests that almost half of the patients receiving “boosts” for PD improve to either PR/CR (18 %) or SD (30 %), irrespective of initial or later progression with nivo. Clinical trial information: NCT02917772. [Table: see text]

Association of the neutrophil to eosinophil ratio with response to immunotherapy-based combinations in metastatic renal cell carcinoma.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 341-341
Author(s):  
Matthew D Tucker ◽  
Katy Beckermann ◽  
Kristin Kathleen Ancell ◽  
Kerry Schaffer ◽  
Renee McAlister ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Clinical Outcomes ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Objective Response ◽  
Progression Free Survival ◽  
Rank Test ◽  
Cancer Center ◽  
Exact Test

341 Background: Neutrophilia is known to be associated with worse prognosis in metastatic renal cell carcinoma (mRCC); however, less is known about the role of eosinophils in the response to immunotherapy (IO). We investigated the association of the baseline neutrophil to eosinophil ratio (NER) with outcomes to IO-based combination treatment in mRCC. Methods: Patients with mRCC treated with ipilimumab plus nivolumab, pembrolizumab plus axitinib, or avelumab plus axitinib at the Vanderbilt-Ingram Cancer Center were retrospectively identified. Patients on >10mg prednisone and patients with prior IO were excluded. Baseline NER (at time of first IO) and association with progression free survival (PFS), overall survival (OS), and objective response rate (ORR) were investigated. Data cutoff was 9/1/2020. Analysis for PFS and OS was performed using the log-rank test and Mantel-Haenszel method, and analysis of the odds ratio for ORR was performed using Fischer’s exact test. Results: Sixty-one patients were identified: 89% clear cell histology, 74% prior nephrectomy, 69% IMDC intermediate risk, and 72% treatment-naïve. Patients with baseline NER < median (N=31) had improved clinical outcomes compared to patients with baseline NER > median (N=30) (Table). Improvement in PFS by NER was maintained when stratified by anti-PD-1/CTLA-4 and anti-PD(L)-1/VEGF (p= 0.0062 and p= 0.049); however, differences in OS and ORR were no longer significant. The median baseline NER among patients with partial response (PR) was significantly lower at 22.7 (95% CI 18.9-31.1) vs. 51.6 (95% CI 39.5-93.1) among those with progressive disease (PD) (p= 0.0054). For comparison, the median neutrophil to lymphocyte ratio was not significantly different between PR (2.60) and PD (3.84, p= 0.056). Conclusions: Patients with a low baseline NER treated with IO-based combinations had improved clinical outcomes compared to patients with a high baseline NER. Additional investigation of this parameter in larger cohorts is warranted. [Table: see text]

Circadian-shaped infusions of floxuridine for progressive metastatic renal cell carcinoma.

1990 ◽  
Vol 8 (9) ◽  
pp. 1504-1513 ◽  
Author(s):  
W J Hrushesky ◽  
R von Roemeling ◽  
R M Lanning ◽  
J T Rabatin
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Continuous Infusion ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Objective Response ◽  
Response Duration ◽  
Hepatic Function ◽  
Survival Duration ◽  
Infusion Schedule

Sixty-eight unselected patients with progressive metastatic renal cell carcinoma (RCC) were treated between March 1985 and November 1988 with continuous infusion floxuridine (FUDR). Thirty-seven percent of these patients had previously received and failed systemic treatment. Using implantable pumps for automatic drug delivery, FUDR was continuously infused for 14 days at monthly intervals. The starting dose was 0.15 mg/kg/d (intravenous [IV]; n = 61) or 0.25 mg/kg/d (intraarterial [IA]; n = 7); IV doses were increased or decreased in increments of 0.025 mg/kg/d as permitted by toxicity. Diarrhea (with or without mild abdominal cramping) and nausea/vomiting limited the FUDR IV infusion, and hepatic function abnormalities limited FUDR IA infusion. The use of a circadian-modified infusion schedule permitted high FUDR doses to be safely given as compared with a constant rate infusion schedule. Of 63 patients assessable for response, 56 received systemic FUDR infusion. Four complete responses (CRs; 7.1%); and seven partial responses (PRs; 12.5%) were observed (objective response rate, CR plus PR, 19.6 +/- 5.1% [95% confidence limits] ). The median objective response duration was 10.8 months (range, 1 to 18 months; mean, 9.4 +/- 1.6). Four additional patients had minor tumor responses (MRs; 7.1%). In a subgroup of seven assessable patients receiving hepatic arterial FUDR, we observed one CR and three PRs (57.2 +/- 42.8%). Overall, objective response (CR plus PR) was seen in a quarter of assessable patients treated, 15 of 63, while only 15 of the 63 assessable patients (25.4%) have had objective tumor progression. The median follow-up time for all 68 patients was 28 months (range, 1 to 42), and their median survival duration is 15 months (range, 3 to 37 months). Continuous infusion FUDR is an effective outpatient treatment for progressive metastatic RCC, producing durable tumor response and causing little toxicity.

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