scholarly journals Surgery for Unresectable Stage IIIC and IV Melanoma in the Era of New Systemic Therapy

Cancers ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1176 ◽  
Author(s):  
Stephanie A. Blankenstein ◽  
Maureen J. B. Aarts ◽  
Franchette W. P. J. van den Berkmortel ◽  
Marye J. Boers-Sonderen ◽  
Alfons J. M. van den Eertwegh ◽  
...  
Keyword(s):  
Disease Control ◽  
Systemic Therapy ◽  
Progression Free Survival ◽  
Complete Response ◽  
Stage Iiic ◽  
Free Survival ◽  
Unresectable Stage ◽  
Melanoma Treatment ◽  
Melanoma Patients

Opportunities for surgical treatment in metastatic melanoma patients have re-emerged due to the development of novel systemic therapeutics over the past decade. The aim of this study is to present data on outcomes of surgery in patients with unresectable stage IIIC and IV melanoma, who have previously been treated with immunotherapy or targeted therapy. Data was extracted from the Dutch Melanoma Treatment Registry (DMTR) on 154 patients obtaining disease control to systemic therapy and undergoing subsequent surgery. Disease control was defined as a complete response (CR), which was seen in 3.2% of patients; a partial response (PR), seen in 46.1% of patients; or stable disease (SD), seen in 44.2% of patients. At a median follow-up of 10.0 months (interquartile range 4–22) after surgery, the median overall survival (OS) had not been reached in our cohort and median progression-free survival (PFS) was 9.0 months (95% CI 6.3–11.7). A CR or PR at first follow-up after surgery was associated with both a better OS and PFS compared to stable or progressive disease (p < 0.001). We conclude that selected patients can benefit from surgery after achieving disease control with systemic therapy.

scholarly journals Surgery for unresectable stage IIIC and IV melanoma in the era of new systemic therapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10032-10032
Author(s):  
Stephanie Blankenstein ◽  
Maureen J.B. Aarts ◽  
Franchette van den Berkmortel ◽  
Marye Boers-Sonderen ◽  
Alfonsus Johannes Maria van den Eertwegh ◽  
...  
Keyword(s):  
Targeted Therapy ◽  
Disease Control ◽  
Systemic Therapy ◽  
Selection Criterion ◽  
Stage Iv ◽  
Stage Iiic ◽  
Term Survival ◽  
Cox Regression Analysis ◽  
Unresectable Stage ◽  
Melanoma Patients

10032 Background: Over the past decade opportunities for surgical treatment in metastatic melanoma patients have re-emerged due to the development of novel systemic therapies. However, selecting patients who will benefit from surgery after systemic therapy is still difficult. The aim of this study is to present data on outcomes of surgery in patients with unresectable stage III and IV melanoma, who have previously been treated with immune checkpoint inhibitors (ICI) or targeted therapy, to provide insight in which patients may benefit from surgery. Methods: Data was extracted from the prospectively collected, nationwide, Dutch Melanoma Treatment Registry (DMTR) onunresectable stage IIIC or advanced/metastatic stage IV melanomapatients who obtained disease control with systemic therapy and underwent subsequent surgery. Disease control was defined as a complete response (CR), partial response (PR) or stable disease (SD). After disease control was achieved with systemic therapy, progressive disease (PD) was allowed as a most recent status of disease prior to surgery, to avoid excluding patients with oligoprogression. Major exclusion criteria were non-cutaneous melanoma and brain metastases. Results: Of 3959 patients in the DMTR database, 154 patients met our inclusion criteria. Of these patients, 79 (51%) were treated with ICI, 61 (40%) with targeted therapy and 9.1% with study or other treatments before surgery. The best response to systemic therapy was a CR in 5.2%, PR in 46.1% and SD in 44.2% of patients. At a median follow-up of 10.0 months (IQR 4-22) after surgery, the median overall survival (OS) had not been reached in our cohort and median progression free survival (PFS) was 9.0 months (95% CI 6.3-11.7). A multivariate cox regression analysis showed that when surgery led to CR or PR, the PFS and OS were better than if surgery led to SD or PD (p < 001). Also, ICI seemed to be more favorable than targeted therapy in both PFS (median of 15 versus 7 months) and OS (median not reached versus 32 months) (p = 0.026 and p = 0.003). Conclusions: We conclude that selected unresectable stage IIIC or stage IV melanoma patients might benefit from surgery after achieving disease control with systemic therapy. Expected residual tumor after surgery could be an important selection criterion. Especially patients undergoing surgery after initial tumor response on ICI have a chance of long-term survival.

Pomalidomide (POM) + low-dose dexamethasone (LoDEX) after lenalidomide (LEN)-based second-line (2L) treatment (Tx) in patients (Pts) with relapsed/refractory multiple myeloma (RRMM): Analysis of progression-free survival (PFS) by level of disease control.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 8027-8027 ◽  
Author(s):  
David Siegel ◽  
Gary J. Schiller ◽  
Kevin W. Song ◽  
Richy Agajanian ◽  
Keith Stockerl-Goldstein ◽  
...  
Keyword(s):  
Partial Response ◽  
Disease Control ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Complete Response ◽  
Second Primary ◽  
Free Survival ◽  
Third Line ◽  
Second Primary Malignancies

8027 Background: Recent trials of triple therapy in 2L and third-line (3L) Tx excluded pts refractory to LEN. This is not reflective of standard of care in first line and 2L where LEN is given until progressive disease (PD). MM-014 enrolled pts with RRMM and 2L LEN-based Tx failure. Here we report results only from cohort A of pts receiving POM + LoDEX. Cohort B will investigate POM + LoDEX + daratumumab. Methods: Adult pts with MM, 2 prior Tx lines, and PD after ≥ 2 cycles of 2L LEN-based Tx received POM + LoDEX. The primary endpoint was overall response rate (ORR). Other endpoints included time to response (TTR), PFS, second primary malignancies (SPMs), and biomarkers. Results: Of 51 pts in cohort A, 39 (76.5%) discontinued Tx. Most pts (88.2%) were refractory to their last LEN Tx, (median Tx duration 24.6 mos) and 72.5% had prior bortezomib. At a median follow-up of 13.6 mos, ORR was 29.4% (2.0% complete response, 9.8% very good partial response, and 17.6% partial response [PR]) and median TTR was 1.9 mos; 66% of pts had ongoing response at 1 yr. Minimal response [MR] was reached in 15.7%. Median PFS was 13.8 mos. Pts with ≥ MR had similar Tx durations as those achieving ≥ PR. Additional results in Table. Post-Tx T-cell populations were significantly higher vs baseline (CD3+, 72.6% vs 67.8%; CD3+/CD8+, 36.9% vs 32.1%). Relative changes from baseline were significantly greater in pts with response vs pts with no response (CD3+, 10.4 vs −0.8; CD3+/CD4+, 4.2 vs −3.5). Conclusions: This update confirms the safety and efficacy of POM + LoDEX following 2L LEN-based Tx failure in pts with RRMM. Hematologic adverse event (AE) rates improved and median PFS was longer with 3L use than previously reported with POM + LoDEX use in later Tx lines. In addition, achieving disease control of ≥ MR led to similar PFS rates as reaching ≥ PR. Clinical trial information: NCT01946477. [Table: see text]

scholarly journals Clinical Presentation, Natural History, and Therapeutic Approach in Patients with Solitary Fibrous Tumor: A Retrospective Analysis

Sarcoma ◽  
2020 ◽  
Vol 2020 ◽  
pp. 1-9 ◽  
Author(s):  
P. Schöffski ◽  
I. Timmermans ◽  
D. Hompes ◽  
M. Stas ◽  
F. Sinnaeve ◽  
...  
Keyword(s):  
Solitary Fibrous Tumor ◽  
Systemic Therapy ◽  
Median Overall Survival ◽  
Progression Free Survival ◽  
Response Rates ◽  
Free Survival ◽  
Metachronous Metastasis ◽  
Third Line ◽  
Fibrous Tumor

Background. Solitary fibrous tumor (SFT) is a rare variant of soft tissue sarcoma (STS). Materials and Methods. We reviewed SFT patients (pts) treated at our institution between 12/1990 and 09/2017. Results. We identified 94 pts with a median follow-up (mFU) of 4.7 years (range: 0.1–21.53). Primary sites were the chest (33%), abdomen (21.3%), brain (12.8%), and extremities (9.6%); 6.4% of pts presented with synchronous metastasis. Median overall survival (mOS) from the first diagnosis was 56.0 months (m) (0.3–258.3). Doege–Potter syndrome was seen in 2.1% of pts. Primary resection was performed in 86 pts (91.5%). Median progression-free survival was 34.1 m (1.0–157.1), and 43% of pts stayed SFT-free during FU. Local recurrence occurred in 26.7% after a mFU of 35.5 m (1.0–153.8), associated with an OS of 45.1 m (4.7–118.2). Metachronous metastasis occurred in 30.2% after a mFU of 36.0 m (0.1–157.1). OS in metastatic pts was 19.0 m (0.3–149.0). Systemic therapy was given to 26 pts (27.7%) with inoperable/metastatic disease. The most common (57.7%) upfront therapy was doxorubicin, achieving responses in 13.3% of pts with a PFS of 4.8 m (0.4–23.8). In second line, pts were treated with ifosfamide or pazopanib, the latter achieving the highest response rates. Third-line treatment was heterogeneous. Conclusion. SFT is an orphan malignancy with a highly variable clinical course and a considerable risk of local failure and metachronous metastasis. Surgery is the only curative option; palliative systemic therapy is used in inoperable/metastatic cases but achieves low response rates. The highest response rates are seen with pazopanib in second/third line.

Nivolumab (NIVO) + low-dose ipilimumab (IPI) as first-line (1L) therapy in microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): Two-year clinical update.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4040-4040 ◽  
Author(s):  
Heinz-Josef Lenz ◽  
Sara Lonardi ◽  
Vittorina Zagonel ◽  
Eric Van Cutsem ◽  
M. Luisa Limon ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Low Dose ◽  
Objective Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Duration Of Response ◽  
Therapy Option ◽  
Grade 3

4040 Background: In the phase 2 CheckMate 142 trial, NIVO + low-dose IPI had robust, durable clinical benefit and was well tolerated as 1L therapy for MSI-H/dMMR mCRC (median follow-up 13.8 months [mo; range, 9–19]; Lenz et al. Ann Oncol 2018;29:LBA18). Longer follow-up is presented here. Methods: Patients (pts) with MSI-H/dMMR mCRC and no prior treatment for metastatic disease received NIVO 3 mg/kg Q2W + low-dose IPI 1 mg/kg Q6W until disease progression or discontinuation. The primary endpoint was investigator-assessed (INV) objective response rate (ORR) per RECIST v1.1. Results: In 45 pts with median follow-up of 29.0 mo, ORR (95% CI) increased to 69% (53–82) (Table) from 60% (44.3–74.3); complete response (CR) rate increased to 13% from 7%. The concordance rate of INV and blinded independent central review was 89%. Median duration of response (DOR) was not reached (Table). Median progression-free survival (PFS) and overall survival (OS) were not reached, and 24-mo rates were 74% and 79%, respectively (Table). Nineteen pts discontinued study treatment without subsequent therapy. An analysis of tumor response post discontinuation will be presented. Ten (22%) pts had grade 3–4 treatment-related adverse events (TRAEs); 3 (7%) had grade 3–4 TRAEs leading to discontinuation. Conclusions: NIVO + low-dose IPI continued to show robust, durable clinical benefit with a deepening of response, and was well tolerated with no new safety signals identified with longer follow-up. NIVO + low-dose IPI may represent a new 1L therapy option for pts with MSI-H/dMMR mCRC. Clinical trial information: NTC02060188 . [Table: see text]

Bortezomib-Melphalan-Prednisone-Thalidomide Followed by Maintenance With Bortezomib-Thalidomide Compared With Bortezomib-Melphalan-Prednisone for Initial Treatment of Multiple Myeloma: Updated Follow-Up and Improved Survival

2014 ◽  
Vol 32 (7) ◽  
pp. 634-640 ◽  
Author(s):  
Antonio Palumbo ◽  
Sara Bringhen ◽  
Alessandra Larocca ◽  
Davide Rossi ◽  
Francesco Di Raimondo ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Response Rate ◽  
Complete Response Rate ◽  
Progression Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Grade 3 ◽  
To Receive

Purpose Bortezomib-melphalan-prednisone (VMP) has improved overall survival in multiple myeloma. This randomized trial compared VMP plus thalidomide (VMPT) induction followed by bortezomib-thalidomide maintenance (VMPT-VT) with VMP in patients with newly diagnosed multiple myeloma. Patients and Methods We randomly assigned 511 patients who were not eligible for transplantation to receive VMPT-VT (nine 5-week cycles of VMPT followed by 2 years of VT maintenance) or VMP (nine 5-week cycles without maintenance). Results In the initial analysis with a median follow-up of 23 months, VMPT-VT improved complete response rate from 24% to 38% and 3-year progression-free-survival (PFS) from 41% to 56% compared with VMP. In this analysis, median follow-up was 54 months. The median PFS was significantly longer with VMPT-VT (35.3 months) than with VMP (24.8 months; hazard ratio [HR], 0.58; P < .001). The time to next therapy was 46.6 months in the VMPT-VT group and 27.8 months in the VMP group (HR, 0.52; P < .001). The 5-year overall survival (OS) was greater with VMPT-VT (61%) than with VMP (51%; HR, 0.70; P = .01). Survival from relapse was identical in both groups (HR, 0.92; P = .63). In the VMPT-VT group, the most frequent grade 3 to 4 adverse events included neutropenia (38%), thrombocytopenia (22%), peripheral neuropathy (11%), and cardiologic events (11%). All of these, except for thrombocytopenia, were significantly more frequent in the VMPT-VT patients. Conclusion Bortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation.

scholarly journals Molecular profiling of advanced malignancies guides first-line N-of-1 treatments in the I-PREDICT treatment-naïve study

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Jason K. Sicklick ◽  
Shumei Kato ◽  
Ryosuke Okamura ◽  
Hitendra Patel ◽  
Mina Nikanjam ◽  
...  
Keyword(s):  
Disease Control ◽  
Progression Free Survival ◽  
Complete Response ◽  
Disease Control Rate ◽  
Unknown Primary ◽  
Combination Therapies ◽  
First Line ◽  
Free Survival ◽  
Treatment Naïve ◽  
Matching Score

Abstract Background Malignancies are molecularly complex and become more resistant with each line of therapy. We hypothesized that offering matched, individualized combination therapies to patients with treatment-naïve, advanced cancers would be feasible and efficacious. Patients with newly diagnosed unresectable/metastatic, poor-prognosis cancers were enrolled in a cross-institutional prospective study. Methods A total of 145 patients were included in the study. Genomic profiling (tissue and/or circulating tumor DNA) was performed in all patients, and PD-L1 immunohistochemistry, tumor mutational burden, and microsatellite status assessment were performed in a subset of patients. We evaluated safety and outcomes: disease-control rate (stable disease for ≥ 6 months or partial or complete response), progression-free survival (PFS), and overall survival (OS). Results Seventy-six of 145 patients (52%) were treated, most commonly for non-colorectal gastrointestinal cancers, carcinomas of unknown primary, and hepatobiliary malignancies (53% women; median age, 63 years). The median number of deleterious genomic alterations per patient was 5 (range, 0–15). Fifty-four treated patients (71%) received ≥ 1 molecularly matched therapy, demonstrating the feasibility of administering molecularly matched therapy. The Matching Score, which reflects the percentage of targeted alterations, correlated linearly with progression-free survival (R2 = 0.92; P = 0.01), and high (≥ 60%) Matching Score was an independent predictor of improved disease control rate [OR 3.31 (95% CI 1.01–10.83), P = 0.048], PFS [HR 0.55 (0.28–1.07), P = 0.08], and OS [HR 0.42 (0.21–0.85), P = 0.02]. Serious adverse event rates were similar in the unmatched and matched groups. Conclusions Personalized combination therapies targeting a majority of a patient’s molecular alterations have antitumor activity as first-line treatment. These findings underscore the feasibility and importance of using tailored N-of-1 combination therapies early in the course of lethal malignancies. Trial registration I-PREDICT (NCT02534675) was registered on August 25, 2015.

scholarly journals Improved Progression-Free Survival for Bulky and Non-Bulky Advanced Stage Diffuse Large B-Cell Lymphoma with Consolidative Radiation Therapy: A Bi-Institutional Analysis

2021 ◽  
Author(s):  
Yusef Ali Syed ◽  
Cecilia Jiang ◽  
Jeffrey Switchenko ◽  
Khadija Kirmani ◽  
Chris Kelsey ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Cell Lymphoma ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Stage Iii ◽  
Bulky Disease ◽  
Free Survival ◽  
Large B Cell Lymphoma

Abstract Background: The role of consolidative radiation therapy (RT) for advanced stage diffuse large B-cell lymphoma (DLBCL) is not fully established. Retrospective data provide evidence for the use of consolidative RT in stage III-IV DLBCL and emerging data from randomized studies address the role of RT in bulky disease for these patients.Methods: Patient with stage III-IV DLBCL treated at two institutions who achieved clinical complete response to systemic therapy were included. Kaplan-Meier analysis was performed to determine the impact of consolidative RT. Univariate and multivariable analyses were performed using a Cox proportional hazards model.Results: One hundred eighty-eight patients received systemic therapy consisting of R-CHOP (79%), another Rituximab-based regimen (9%), or chemotherapy alone (12%). Clinical response was assessed using conventional CT or PET-CT. Sixty-eight patients (36%) received consolidative RT (median dose 30 Gy). Consolidative RT conferred a 36.7% absolute benefit in five-year progression-free survival (85.9% vs. 49.2%, log rank p < 0.0001), and a 14.5% absolute benefit in five-year overall survival (87.4% vs. 72.9%, log rank p = 0.0134). On multivariable analysis, consolidative RT was associated with improved PFS (HR 0.23, 95% CI 0.10-0.52, p < 0.001). Patients receiving consolidative RT demonstrated significantly improved PFS for tumors measuring both <5 cm (log rank p = 0.0454) and ³5 cm (log rank p = 0.0003).Conclusions: For patients with stage III-IV DLBCL who achieve clinical complete response after systemic therapy, consolidative RT improves PFS for all patients, including those with non-bulky disease. This benefit persists in the setting of rituximab-based systemic therapy.

scholarly journals Risk tolerance in adjuvant and metastatic melanoma settings: a patient perspective study using the threshold technique

2021 ◽  
Author(s):  
Carol Mansfield ◽  
Kelley Myers ◽  
Kathleen Klein ◽  
Jeetvan Patel ◽  
Antonio Nakasato ◽  
...  
Keyword(s):  
Stage Iv ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Risk Tolerance ◽  
Stage Iii ◽  
Acceptable Risk ◽  
Treatment Benefit ◽  
Free Survival ◽  
Unresectable Stage ◽  
Melanoma Patients

Background: Adverse events (e.g., pyrexia) may affect treatment patterns and adherence. This study explored pyrexia risk tolerance among melanoma patients when treatment benefit is unknown versus known. Materials & methods: US respondents with stage III (n = 100) or stage III unresectable/stage IV melanoma (n = 125) chose between hypothetical melanoma treatments, defined by reoccurrence/progression-free survival and pyrexia risk, one resembling standard-of-care and one resembling dabrafenib + trametinib. Respondents chose first when efficacy was unknown and then when efficacy was known; pyrexia risk was varied systematically to define maximum acceptable risk. Results: Maximum acceptable risk of pyrexia was statistically significantly higher when efficacy was known versus unknown in stage III patients (85 vs 34%) and stage III unresectable/stage IV patients (66 vs 57%). Conclusion: Patients accepted higher levels of pyrexia risk when they understood treatment benefit.

scholarly journals Response Evaluation and Survival Prediction Following PD‐1 Inhibitor in Patients With Advanced Hepatocellular Carcinoma: Comparison of the RECIST 1.1, iRECIST, and mRECIST Criteria

2021 ◽  
Vol 11 ◽  
Author(s):  
Meng Zhou ◽  
Chunhui Zhang ◽  
Jianhua Nie ◽  
Yajuan Sun ◽  
Ye Xu ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Progression Free Survival ◽  
Response Assessment ◽  
Complete Response ◽  
Survival Prediction ◽  
Advanced Hepatocellular Carcinoma ◽  
Free Survival ◽  
Recist 1.1 ◽  
Cell Death Protein

BackgroundPrecise evaluation of the efficacy of immunotherapy is critical in the effective management and treatment of advanced hepatocellular carcinoma (HCC). Therefore, the purpose of this study was to compare the response assessments achieved by different criteria and to evaluate the correlation between survival outcome and response assessment in HCC treated with programmed cell death protein 1 (PD-1) inhibitor.MethodsFifty patients with advanced HCC treated with first-line PD-1 inhibitor with baseline and follow‐up CT images were analyzed. The patients were categorized into responders and nonresponders according to the criteria.ResultsWhen the response assessments between RECIST 1.1 and mRECIST were compared, no statistically significant differences were observed. Overall response rate was 16% by RECIST 1.1 and iRECIST and was 24% by mRECIST. According to RECIST 1.1 and mRECIST, overall survival (OS) and progression-free survival (PFS) were not statistically different between the complete response (CR) and partial response (PR) groups and the stable disease (SD) and progressive disease (PD) groups. The OS and PFS were significantly different between responders and nonresponders according to mRECIST. The Cohen’s Kappa for RECIST 1.1, iRECIST, and mRECIST was 0.534, 0.438, and 0.363, respectively.ConclusionThe mRECIST criteria have a powerful ability to discriminate between responders and nonresponders and demonstrated significantly longer OS and PFS in responders than in nonresponders. However, mRECIST needs to be further improved in order for it to be widely used in the clinical evaluation of immunotherapy in HCC.

Cessation of VEGF-targeted therapy in patients with metastatic renal cell carcinoma (mRCC): Feasibility and clinical outcome.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 307-307
Author(s):  
S. Sadeghi ◽  
L. Albiges ◽  
L. S. Wood ◽  
S. L. Black ◽  
T. D. Gilligan ◽  
...  
Keyword(s):  
Disease Control ◽  
Expectant Management ◽  
Progression Free Survival ◽  
Initial Response ◽  
Free Survival ◽  
Ifn Alpha ◽  
Amg 386 ◽  
Progression Of Disease

307 Background: Standard practice in the treatment (tx) of mRCC with VEGF targeted agents is continuous tx until progression of disease (PD) or unacceptable toxicity. Chronic mild to moderate toxicity and risk of long-term toxicity ensue for a subset of pts. It is hypothesized that a subset of pts with an initial response to tx can maintain disease control off all tx for a period of time. Methods: A retrospective study of mRCC pts who initiated VEGF-targeted tx between January 2004 and November 2009 was conducted. Pts had achieved disease control on tx, then were taken off all tx. Pt, disease and tx characteristics were recorded. Progression free survival (PFS) was measured as the time from discontinuation of tx to RECIST PD. Results: A total of 30 pts were identified. All pts had prior nephrectomy and had clear cell histology, and 9 patients had prior immunotherapy. At the time tx was stopped 16 pts were receiving sunitinib, 7 pts were receiving sorafenib (2 in combination with AMG 386), and 7 pts were receiving bevacizumab (6 in combination with temsirolimus, 1 with IFN-alpha). Six pts had achieved CR, 19 PR and 5 SD by RECIST. Using Heng's prognostic risk group criteria, 14 pts had favorable, 14 had intermediate, and 2 had poor risk disease prior to initiation of VEGF-targeted tx. Therapy was held for severe adverse events (5pts; 2 MIs, 3 CVAs), toxicity (16 pts; 4 diarrhea, 3 skin, 3 proteinuria, 2 cardiac, 1 fatigue, 1 stomatitis, 1 pneumonitis, 1 nausea), cost (1 pt; high co-pay), pt choice (6 pts) and interventions (2 pts; 1 angioplasty and 1 kidney stone). Median follow up is 29 months (range 11– 82). Median duration of tx prior to discontinuation was 14.6 months (range 3–79). Thirteen pts (43%) had PD off tx (lymph nodes (6), lungs (8; 3 with new lesions), bones (1), brain (2; 1 with new lesions)) with a median PFS of 10 months (range 3–27). After PD, 4 pts were offered sunitinib, 1 pazopanib, 1 everolimus, 1 local RF tx, and 6 continued expectant management. After a median follow-up to date of 7.5 months (2–28), 17 pts (57%) still did not have RECIST PD. Conclusions: Select mRCC pts with disease control on VEGF-targeted tx can be safely observed off all tx. Further prospective investigation is needed to define the risks and benefits of this approach. [Table: see text]

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