A phase II trial to assess the activity of MVA5T4 plus interleukin-2 in patients (Pts) with metastatic renal cell carcinoma (MRCC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14642-14642 ◽  
Author(s):  
A. Gary ◽  
L. Marsh ◽  
M. McDonald ◽  
S. Naylor ◽  
R. Harrop ◽  
...  
Keyword(s):  
Immune Response ◽  
Clinical Outcome ◽  
Renal Cell ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Recovery Period ◽  
Interleukin 2 ◽  
Human Tumor ◽  
Prior Therapy ◽  
Number Of Patients

14642 Background: MVA 5T4 consists of a highly attenuated vaccinia virus (modified Vaccinia Ankara, MVA) containing the human tumor associated antigen (TAA) 5T4. Greater than 90% of renal cell cancers are overexpressed by the 5T4 antigen. The primary purpose of this trial is to validate the hypothesis that, in this group of pts, it is possible to induce immune responses either humoral and/or cellular to 5T4 and to break tolerance to the antigen. The immune response will be correlated to clinical outcome. Methods: Eligibility included: pathologic diagnosis of confirmed clear cell or papillary cancer, progressive measurable MRCC, adequate organ/marrow function, Karnofsky Performance Status (KPS) ≥ 80%, any prior therapy, and no active CNS involvement. The dosage schedule of subcutaneous low dose IL-2 will be an initial dose 250,000 U/kg/dose for 5 days in week 1 followed by 125,000 U/kg/dose for 5 days each of weeks 2–6 inclusive. There will then be a 2 week recovery period before the next cycle commences. The dosage regimen of MVA 5T4 will be intramuscular injections given 14 days prior to the first cycle, day 0 and 1 injection given at the beginning of week 4 of the first cycle. In subsequent cycles, booster injections of MVA 5T4 will be given at week 1 only, prior to the commencement of subcutaneous IL-2 therapy. Results: 10 pts have been treated with MVA 5T4 and the LD IL2 regimen. The combination has been extremely well tolerated with no MVA 5T4 related events thus far. Although the study is still continuing to accrue, there are early signs of clinical responses in a number of patients receiving the combination. The immunological analysis is in progress. Conclusion: MVA 5T4 is well tolerated in this group of patients. The immune response will be presented along with clinical outcome. [Table: see text]

Activity of cabozantinib (XL184) in patients (pts) with metastatic, refractory renal cell carcinoma (RCC).

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 364-364 ◽  
Author(s):  
Toni K. Choueiri ◽  
Sumanta Kumar Pal ◽  
David F. McDermott ◽  
David A. Ramies ◽  
Stephanie Morrissey ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Tumor Regression ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Primary Objective ◽  
Risk Category ◽  
Efficacy Evaluation ◽  
Prior Therapy

364 Background: Cabozantinib (cabo) is an oral, potent inhibitor of MET and VEGFR2 that is currently undergoing clinical efficacy evaluation in several oncology indications. Renal cell carcinoma (RCC) was chosen as an indication in this drug-drug interaction (DDI) study based on involvement of the MET and VEGFR signaling pathways in this disease. The primary objective of this study is to determine the effect of cabo on single dose PK of the CYP2C8 substrate rosiglitazone (rosi). The exploratory objective of this study is to evaluate the preliminary antitumor activity of cabo in pts with RCC. Methods: Eligible pts were required to have RCC with clear cell components with metastases, Karnofsky performance status of ≥70 and measurable disease by RECIST. Pts needed to have experienced PD following standard therapies. Method for DDI study: Day 1, 4 mg rosi; Days 2 - 22, cabo given daily at a dose of 175 mg; Day 22, 4 mg rosi to complete PK assessment for DDI. Cabo continued until PD. On Day 57 and every 8 weeks thereafter subjects underwent tumor assessments by mRECIST. Results: Enrollment is complete at 25 RCC pts with a median of 2 prior regimens; 17/25 (68%) RCC pts had received ≥ 2 lines of prior therapy and 13/25 (52%) with at least 1 VEGF pathway inhibitor and 1 mTOR inhibitor. All pts were intermediate (24/25) or poor (1/25) risk category per Heng et al prognostic strata (JCO 2009). Related AEs ≥ Grade 3 severity: hypophosphatemia 8 (32%), PE 3 (12%; all were incidental / resolved) and diarrhea 3 (12%). Preliminary PK data suggest that clinically relevant doses of cabo do not markedly alter the Cmax or AUC0-24h of rosi consistent with lack of inhibition of CYP2C8. RCC pts with confirmed PR by mRECIST: 6/25 (24%). Additionally, 1 pt had an unconfirmed PR. Disease control rate (PR + SD): 68% at 16 weeks; 18/21 (86%) pts with ≥1 post-baseline scan experienced tumor regression (range: 4 – 63% reduction in measurements). 14/25 (56%) remain on cabo with a median follow-up of 4 months. Median PFS and OS have not been reached. Conclusions: Cabo demonstrates encouraging anti-tumor activity in heavily pretreated pts with RCC with a toxicity profile similar to that of other TKIs. Preliminary data suggest no DDI between cabo and rosi (CYP2C8 substrate).

Phase I/II Trial to Evaluate the Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel in Combination With Gemcitabine in Patients With Pancreatic Cancer and an ECOG Performance Status of 2

2019 ◽  
Vol 37 (3) ◽  
pp. 230-238 ◽  
Author(s):  
Teresa Macarulla ◽  
Roberto Pazo-Cid ◽  
Carmen Guillén-Ponce ◽  
Rafael López ◽  
Ruth Vera ◽  
...  
Keyword(s):  
Phase I ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Phase Ii ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Ductal Adenocarcinoma ◽  
Tolerability Profile ◽  
Ecog Performance Status ◽  
Actuarial Survival ◽  
Number Of Patients

Purpose Gemcitabine plus nanoparticle albumin-bound (NAB) paclitaxel (GA) significantly improved survival compared with gemcitabine alone in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) and a Karnofsky performance status (PS) of 70% or greater. Because of the low number of patients with reduced PS, the efficacy of this regimen in fragile patients remains unclear. This study aimed to evaluate the efficacy and tolerability of different GA dosing regimens in patients with a poor PS. Patients and Methods In the phase I part of this study, patients were randomly assigned to one of the following four parallel GA treatment arms (six patients per arm): a biweekly schedule of NAB-paclitaxel (150 mg/m2 [arm A] or 125 mg/m2 [arm C]) plus gemcitabine 1,000 mg/m2 or a standard schedule of 3 weeks on and 1 week off of NAB-paclitaxel (100 mg/m2 [arm B] or 125 mg/m2 [arm D]) plus gemcitabine 1,000 mg/m2. The two regimens with the better tolerability profile on the basis of predefined criteria were evaluated in the phase II part of the study, the primary end point of which was 6-month actuarial survival. Results Arms B and D were selected for the phase II part of the study. A total of 221 patients (111 patients in arm B and 110 patients in arm D) were enrolled. Baseline characteristics including median age (71 and 68 years in arms B and D, respectively), sex (51% and 55% men in arms B and D, respectively), and metastatic disease (88% and 84% in arms B and D, respectively) were comparable between arms. The most frequent grade 3 or 4 toxicities in arms B and D were anemia (12% and 7%, respectively), neutropenia (32% and 30%, respectively), thrombocytopenia (7% and 11%, respectively), asthenia (14% and 16%, respectively), and neurotoxicity (11% and 16%, respectively). In arms B and D, there were no significant differences in response rate (24% and 28%, respectively), median progression-free survival (5.7 and 6.7 months, respectively), and 6-month overall survival (63% and 69%, respectively). Conclusion NAB-paclitaxel administered at either 100 and 125 mg/m2 in combination with gemcitabine on days 1, 8, and 15 every 28 days is well tolerated and results in acceptable safety and efficacy in patients with metastatic pancreatic ductal adenocarcinoma and a poor PS.

Interferon alfa-2a in advanced renal cell carcinoma: treatment results and survival in 159 patients with long-term follow-up.

1993 ◽  
Vol 11 (7) ◽  
pp. 1368-1375 ◽  
Author(s):  
L M Minasian ◽  
R J Motzer ◽  
L Gluck ◽  
M Mazumdar ◽  
V Vlamis ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Prognostic Factors ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Interferon Alfa ◽  
Advanced Renal Cell Carcinoma ◽  
Survival Duration

PURPOSE Three trials were conducted to define the efficacy and toxicity of interferon alfa-2a in the treatment of metastatic renal cell cancer. Univariate and multivariate analyses were performed to identify prognostic factors for survival. PATIENTS AND METHODS Prospectively, 159 patients were treated with interferon alfa-2a. In the first trial, 42 patients received 50 x 10(6) U/m2 intramuscularly three times per week. In the second trial, 64 patients received gradually escalating doses of interferon alfa-2a from 3 to 36 x 10(6) U subcutaneously administered daily. The third trial was randomized; 25 patients received daily interferon alfa-2a alone and 28 were treated with daily interferon alfa-2a and 0.15 mg/kg vinblastine every 3 weeks. RESULTS The overall response proportion was 10% (two complete and 14 partial responses). The median response duration was 12.2 months. The median survival duration was 11.4 months, with 3% of patients alive at 5 or more years. A univariate statistical analysis showed that a Karnofsky performance status > or = 80, prior nephrectomy, and interval from diagnosis to treatment of longer than 365 days were significant prognostic factors for survival. In a multivariate analysis, only prior nephrectomy and Karnofsky performance status > or = 80 were shown to be independent predictors of survival. CONCLUSION Interferon alfa-2a had minimal antitumor activity in patients with advanced renal cell carcinoma and long-term survival was achieved in a small proportion of patients. The need for continued investigation and the identification of more effective therapy for advanced renal cell carcinoma is evident from the poor overall survival rate observed in these 159 patients. The investigation of new agents and of interferon alfa-2a in combination with other agents remains a priority.

scholarly journals Delayed Cytoreductive Nephrectomy Following Three Years of Targeted Therapy for Metastatic Renal Cell Carcinoma

2015 ◽  
Vol 9 (4) ◽  
pp. 202-208
Author(s):  
Ariel Schulman ◽  
Mathew Fakhoury ◽  
Jean P. Wuilleumier ◽  
Kevin Becker ◽  
Bernadine Donahue ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Performance Status ◽  
Interleukin 2 ◽  
Cytoreductive Nephrectomy ◽  
Prognostic Features ◽  
Good Performance Status ◽  
Patient Reported

We present a 55-year-old male, with good performance status who was diagnosed with a case of metastatic renal cell carcinoma following a pathologic femur fracture. Despite good performance status, multifocal metastases and poor-prognostic features portended a grim prognosis with predicted overall survival of less than nine months. On initial presentation, he was excluded from cytoreductive nephrectomy based on brain metastasis and interleukin-2 was not pursued as the primary tumor was to be left in situ. The patient was reconsidered for cytoreductive nephrectomy after sustained response to fifth line targeted therapies with shrinkage of tumor burden. The post-operative course was uneventful and the patient was discharged home on postoperative day one. Temsirolimus was resumed one week after surgery and the patient reported returning to his normal activities at the two week follow-up visit. We highlight important clinical features of metastatic renal cell carcinoma, the surgical considerations for cytoreductive nephrectomy and the detailed multidisciplinary care the patient received throughout this case report.

Activity of MVA 5T4 alone or in combination with either interleukin-2 (IL-2) or interferon-α (IFN) in patients (Pts) with metastatic renal cell cancer (MRCC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 3069-3069
Author(s):  
A. Cao ◽  
J. Hernandez-McClain ◽  
J. Willis ◽  
R. Harrop ◽  
W. Shingler ◽  
...  
Keyword(s):  
Clear Cell ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Cell Cancer ◽  
Single Agent ◽  
Locally Advanced ◽  
Interleukin 2 ◽  
Future Research ◽  
Interferon Α ◽  
Clinical Activity

3069 Background: MVA 5T4 consists of the highly attenuated modified Vaccinia Ankara virus containing the gene encoding the human TAA 5T4. Ninety percent or more of RCCs overexpress the 5T4 antigen. A series of clinical trials were conducted to evaluate the effectiveness of MVA 5T4 as a single agent or in combination with Interleukin-2 or Interferon Alpha 2B. Methods: Eligibility: pathologic diagnosis of clear cell or papillary RCC, progressive measurable metastases, any prior therapy, adequate physiologic parameters, Karnofsky performance status (KPS) = 80%, and no active CNS involvement. A regimen of MVA 5T4 alone or in combination with IFN or IL-2 was given. Results: A total of 41 patients received MVA 5T4 alone or in combination. 33 patients received MVA 5T4 with low dose IL-2 or IFN. 23 pts had clear cell; 12 papillary; 5 mixed clear cell; and 1 mixed papillary. 19 pts continue to receive therapy. 2 pts (both clear cell RCC) developed complete responses, 3 pts/partial responses (2 clear cell, 1 papillary) 8 pts/stable for 3+months and 6 pts are too early to be staged at this time. Median duration of therapy is 3.0+ (1+-13+) months. Conclusion: Although comparable antibody response were observed in papillary and clear cell histotypes, clear cell patients appeared to be more likely to respond in terms of clinical benefit parameters, to be presented. Of note is that preliminary analysis of clear cell patients suggests a relationship between the anti-5T4 immune response and tumor response. With the immunological potency and encouraging clinical activity, the future research will focus on the phase 3 randomized, double-blind, placebo controlled parallel group study to investigate whether MVA 5T4, added to first line standard of care therapy, prolongs the survival of patients with locally advanced or metastatic clear cell as well as studies to further optimize MVA 5T4 potency. [Table: see text]

High-dose bolus interleukin-2 in elderly patients (>60 years old) with metastatic melanoma or renal cell cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19559-19559
Author(s):  
J. Homsi ◽  
L. C. Kim ◽  
D. Goetz ◽  
D. Chen ◽  
M. Fishman ◽  
...  
Keyword(s):  
Side Effects ◽  
Metastatic Melanoma ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Cell Cancer ◽  
Interleukin 2 ◽  
The Elderly ◽  
Median Number ◽  
High Dose ◽  
Number Of Patients

19559 Background: Although durable complete responses have been reported from using high-dose bolus interleukin-2 (HDB IL-2) in a small number of patients with metastatic melanoma and renal cell cancer (RCC), IL-2 toxicity limits its use especially in the elderly. Methods: the medical records of patients older than 60 years old with melanoma or renal cell carcinoma who received HDB IL-2 at the Moffitt Cancer Center between 2000–2005 were reviewed. The effect of increased age, primary diagnosis, and the HDB IL-2 regimen used on the side effects, number of administered doses, and survival was analyzed. Results: 55 cycles were administered to 35 patients (23 RCC, 12 melanoma, 26 men). Median age was 67 years old (range: 61–77). 17 patients received a traditional regimen (one cycle: 600,000 IU/Kg intravenously every 8 hours for 14 doses repeated in 2 weeks, maximum of 28 doses) and 18 received a clinical trial regimen (one cycle: 600,000 IU/Kg intravenously every 8 hours for 5 doses repeated weekly, maximum of 20 doses). Median number of administered cycles was 1 (range 1–4) and median number of total doses was 24 (range 3–79). Increased age was not related to total number of administered doses. Median percentage of IL-2 administered in a cycle was 75% of planned (range 11%-100%). Reasons to discontinue therapy were: oliguria (35%), hypotension (25%), and arrhythmia (15%). Side effects in all cycles were: hypotension (71%), oliguria (67%), Arrhythmia (18%), Myocardial infarction (7%), pulmonary edema (7%), hypothyroidism (4%), confusion (4%), seizures (2%) and stroke (2%). Pressors were used in 58% of all cycles. 20 patients died within a year from starting treatment and 5 lived more than 2 years (4 had RCC). Conclusions: 1) HDB IL-2 has multiple and life-threatening side effects in the elderly and caution is needed when selecting these patients to such therapy 2) the number of doses administered is comparable to that general population 3) more studies are needed to identify the population that would mostly benefit from HDB IL2. [Table: see text] No significant financial relationships to disclose.

Efficacy of cabozantinib (XL184) in patients (pts) with metastatic, refractory renal cell carcinoma (RCC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4504-4504 ◽  
Author(s):  
Toni K. Choueiri ◽  
Sumanta Kumar Pal ◽  
David F. McDermott ◽  
David A. Ramies ◽  
Stephanie Morrissey ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Tumor Regression ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Primary Objective ◽  
Heavily Pretreated ◽  
Cell Components ◽  
Anti Tumor Activity

4504 Background: Cabozantinib (cabo) is an oral, potent inhibitor of MET and VEGFR2 that is currently undergoing evaluation in several oncology indications. Renal cell carcinoma (RCC) was chosen as an indication in this drug-drug interaction (DDI) study based on involvement of the MET and VEGFR signaling pathways in this disease. The primary objective of this study is to determine the effect of cabo on single dose PK of the CYP2C8 substrate rosiglitazone (rosi). Anti-tumor activity was also evaluated. Methods: Eligible pts were required to have RCC with clear cell components with metastases, Karnofsky performance status of ≥70 and measurable disease by RECIST. Pts needed to have experienced PD following standard therapies. Cabo was given daily at a dose of 140 mg free base (equivalent to 175 mg salt form) starting at Day 2. Rosi (4 mg) was given Day 1 and Day 22 to complete PK assessment for DDI. Cabo was continued until PD. On Day 57 and every 8 weeks thereafter subjects underwent tumor assessments by mRECIST. Results: Enrollment is complete at 25 RCC pts; 17/25 (64%) RCC pts had received ≥ 2 prior agents; 13/25 (52%) with at least 1 VEGF pathway inhibitor and 1 mTOR inhibitor. The majority of pts were in an intermediate (21/25) or poor (3/25) prognostic category (1/25 in favorable category) per Heng et al (JCO, 2009, v27, p5794). ORR by mRECIST: 7/25 (28%). Disease control rate (PR + SD): 72% at 16 weeks; 19/21 (90%) pts with ≥1 post-baseline scan experienced tumor regression (range: 4 - 63% reduction in measurements). 10/25 (36%) pts remain on cabo. Median PFS is 14.7 months (95% CI: 7.3, upper limit not reached) with a median follow-up of 7.7 months. AEs ≥ Grade 3 severity: hypophosphatemia (36%), hyponatremia (20%), and fatigue (16%). PK data suggest that clinically relevant doses of cabo do not alter the Cmax or AUC0-24h of rosi, consistent with no inhibition of CYP2C8. Conclusions: Cabo demonstrates encouraging anti-tumor activity in heavily pretreated RCC pts with a toxicity profile similar to that of other VEGFR TKIs. PK data suggest no DDI between cabo and rosi (CYP2C8 substrate).

A multicentered population-based analysis of outcomes of patients with metastatic renal cell carcinoma (mRCC) who do not meet eligibility criteria for clinical trials.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 353-353 ◽  
Author(s):  
Daniel Yick Chin Heng ◽  
Toni K. Choueiri ◽  
Jae-Lyun Lee ◽  
Lauren Christine Harshman ◽  
Georg A. Bjarnason ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Targeted Therapy ◽  
Brain Metastases ◽  
Clear Cell ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Progression Free Survival ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Number Of Patients

353 Background: Clinical trials have strict eligibility criteria to maintain internal validity. These criteria exclude many patients to whom the trial results are later applied to in clinical practice. Patients that do not meet eligibility criteria are poorly characterized. Methods: mRCC patients treated with VEGF targeted therapy were retrospectively deemed ineligible for clinical trials (according to commonly used inclusion/exclusion criteria) if they had a Karnofsky Performance Status (KPS) < 70%, brain metastases, non-clear cell histology, hemoglobin ≤ 9 g/dL, creatinine > 2x the upper limit of normal, platelet count of < 100x103/uL, neutrophil count < 1500/mm3 or corrected calcium ≤ 12 mg/dL. Results: 894/2076 (43%) patients were deemed ineligible for clinical trials by the above criteria. Between ineligible versus eligible patients, the response rate, median progression free survival (PFS) and median overall survival of first-line targeted therapy were 21% vs 29%, 5.2 vs 8.8 months and 14.5 vs 28.8 months (all p < 0.0001), respectively. Second-line PFS (if applicable) was 3.2 months in the trial ineligible vs 4.4 months in the trial eligible patients (p = 0.0074). When adjusted by the Heng et al prognostic categories, the hazard ratio for death between trial ineligible vs trial eligible patients was 1.621 (95% CI = 1.431–1.836, p < 0.0001). If only KPS, brain metastases and non-clear cell histology were used as exclusion criteria, 672 (32%) patients were excluded and the results were similar. Conclusions: The number of patients that are ineligible for clinical trials is high and their outcomes are inferior. Designing more inclusive clinical trials for this “ineligible” patient population are needed. [Table: see text]

Lymphopenia and clinical outcome of elderly patients treated with sunitinib for metastatic renal cell cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15615-e15615
Author(s):  
Ugo De Giorgi ◽  
Karim Rihawi ◽  
Michele Aieta ◽  
Giovanni Lo Re ◽  
Teodoro Sava ◽  
...  
Keyword(s):  
Clinical Outcome ◽  
Elderly Patients ◽  
Renal Cell Cancer ◽  
Renal Cell ◽  
Performance Status ◽  
Cell Cancer ◽  
Progression Free Survival ◽  
First Line ◽  
Metastatic Renal Cell Cancer ◽  
Grade 3

e15615 Background: Lymphopenia is associated with toxicity and outcome in several cancer types. We assessed the association of pre-treatment lymphopenia with toxicity and clinical outcome of elderly patients with metastatic renal cell cancer treated with first-line sunitinib. We evaluated the prognostic factors in these patients. Methods: We reviewed the clinical files of 181 patients aged >70 years with mRCC treated with first-line sunitinib in seventeen Italian Oncology Units from February 2006 to September 2011. Baseline lymphopenia was defined as lymphocyte counts <1,000/µL. Results: Twenty–nine patients (16.0%) had a baseline lymphocyte counts <1,000/µL, and 152 (84%) ≥1,000/µL. No difference between the two groups was reported in overall response rate (p = 0.207), dose reductions (p = 0.740); discontinuations due to adverse events (p = 0.175), overall incidence of grade 3-4 toxicities (p = 0.112) even if more patients in the group with lymphopenia had grade 3-4 neutropenia (p = 0.017), grade 3-4 thrombocytopenia (p = 0.017) and grade 3-4 diarrhea (p = 0.006). In multivariate analysis, performance status and Heng score were predictors of progression-free survival (p = 0.015 and p = 0.0006, respectively), while performance status, Heng score, and lymphopenia were found to be significantly associated with overall survival (p = 0.007, p < 0.0001 and p = 0.023, respectively). Conclusions: Sunitinib appeared safe and active in elderly patients with lymphopenia. Lymphocyte counts is an independent prognostic factor for OS in elderly patients with mRCC treated with first-line sunitinib.

Outcome Predictors of Gamma Knife Radiosurgery for Renal Cell Carcinoma Metastases

Neurosurgery ◽  
2011 ◽  
Vol 69 (6) ◽  
pp. 1232-1239 ◽  
Author(s):  
Hideyuki Kano ◽  
Aditya Iyer ◽  
Douglas Kondziolka ◽  
Ajay Niranjan ◽  
John C. Flickinger ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Brain Metastases ◽  
Cell Carcinoma ◽  
Stereotactic Radiosurgery ◽  
Median Survival ◽  
Renal Cell ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Gamma Knife Radiosurgery ◽  
Tumor Control

Abstract BACKGROUND Although whole-brain radiation therapy (WBRT) has been a standard palliative management for brain metastases from renal cell carcinoma, its benefit has been elusive because of radiobiological resistance. OBJECTIVE To evaluate the role of stereotactic radiosurgery (SRS) in the management of brain metastases from renal cell carcinoma. METHODS We reviewed records from 158 consecutive patients (men = 111, women = 47) who underwent SRS for 531 brain metastases from renal cell carcinoma. The median patient age was 61 years (range, 38-83 years), and the median number of tumors per patient was 1 (range, 1–10). Seventy-nine patients (50%) had solitary brain metastasis. Fifty-seven patients (36%) underwent prior WBRT. The median total tumor volume for each patient was 3.0 cm3 (range, 0.09-47 cm3). RESULTS The overall survival after SRS was 60%, 38%, and 19% at 6, 12, and 24 months, respectively, with a median survival of 8.2 months. Factors associated with longer survival included younger age, longer interval between primary diagnosis and brain metastases, lower recursive partitioning analysis class, higher Karnofsky performance status, smaller number of brain metastases, and no prior WBRT. Median survival for patients with &gt; 2 brain metastases, higher Karnofsky performance status (&gt; 90), and no prior WBRT was 12 months after SRS. Sustained local tumor control was achieved in 92% of patients. Symptomatic adverse radiation effects occurred in 7%. Overall, 70% of patients improved or remained neurologically stable. CONCLUSION Stereotactic radiosurgery is an especially valuable option for patients with higher Karnofsky performance status and smaller number of brain metastases from renal cell carcinoma.

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