Phase III Multicenter Randomized Trial of the Dartmouth Regimen Versus Dacarbazine in Patients With Metastatic Melanoma

1999 ◽  
Vol 17 (9) ◽  
pp. 2745-2745 ◽  
Author(s):  
Paul B. Chapman ◽  
Lawrence H. Einhorn ◽  
Michael L. Meyers ◽  
Scott Saxman ◽  
Alicia N. Destro ◽  
...  
Keyword(s):  
Survival Time ◽  
Tumor Response ◽  
Stage Iv ◽  
Phase Iii ◽  
Phase Ii Trials ◽  
Phase Iii Trial ◽  
Melanoma Patients ◽  
Intent To Treat ◽  
To Receive ◽  
Stage Iv Melanoma

PURPOSE: Several single-institution phase II trials have reported that the Dartmouth regimen (dacarbazine, cisplatin, carmustine, and tamoxifen) can induce major tumor responses in 40% to 50% of stage IV melanoma patients. This study was designed to compare the overall survival time, rate of objective tumor response, and toxicity of the Dartmouth regimen with standard dacarbazine treatment in stage IV melanoma patients. PATIENTS AND METHODS: In this multicenter phase III trial, 240 patients with measurable stage IV melanoma were randomized to receive the Dartmouth regimen (dacarbazine 220 mg/m2 and cisplatin 25 mg/m2 days 1 to 3, carmustine 150 mg/m2 day 1 every other cycle, and tamoxifen 10 mg orally bid) or dacarbazine 1,000 mg/m2. Treatment was repeated every 3 weeks. Patients were observed for tumor response, survival time, and toxicity. RESULTS: Median survival time from randomization was 7 months; 25% of the patients survived ≥ 1 year.There was no difference in survival time between the two treatment arms when analyzed on an intent-to-treat basis or when only the 231 patients who were both eligible and had received treatment were considered. Tumor response was assessable in 226 patients. The response rate to dacarbazine was 10.2% compared with 18.5% for the Dartmouth regimen (P = .09). Bone marrow suppression, nausea/vomiting, and fatigue were significantly more common in the Dartmouth arm. CONCLUSION: There was no difference in survival time and only a small, statistically nonsignificant increase in tumor response for stage IV melanoma patients treated with the Dartmouth regimen compared with dacarbazine. Dacarbazine remains the reference standard treatment for stage IV melanoma.

Validation of a multimarker blood assay for postoperative assessment of stage IV melanoma patients in a prospective international phase III trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9045-9045
Author(s):  
S. Hoshimoto ◽  
T. Shingai ◽  
H. Wang ◽  
R. M. Elashhoff ◽  
D. L. Morton ◽  
...  
Keyword(s):  
Prognostic Factor ◽  
Risk Ratio ◽  
Clinical Utility ◽  
Stage Iv ◽  
Molecular Biomarkers ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Qrt Pcr ◽  
Melanoma Patients ◽  
Stage Iv Melanoma

9045 Background: Currently there are no validated prognostic molecular biomarkers for assessment of outcome after complete resection of stage IV melanoma patients. To validate blood molecular biomarkers for prognostic value and monitoring of these patients, we evaluated the clinical utility of a multimarker quantitative reverse-transcription PCR (qRT-PCR) for detecting circulating tumor cells (CTC) of patients blood enrolled in a multicenter international (29 sites) phase III trial of postoperative adjuvant therapy. After complete metastasectomy, AJCC stage IV patients underwent immunotherapy with bacille Calmette-Guerin (BCG) plus placebo or BCG plus melanoma vaccine. Methods: Bleeds were taken before and during treatment in both randomized treatment arms. Pre- and during treatment bleeds from patients were assessed by an optimized qRT-PCR assay for MART1, MAGEA3, and PAX3 genes mRNA. Median clinical follow-up time was 21.8 and 24.2 mos. for disease-free survival (DFS) and overall survival (OS), respectively. Results: MART1, MAGEA3, and PAX3 were detected in 64 (26%), 56 (23%), 73 (29%) of 244 post-operative pretreatment patients, respectively. Multivariate Cox analysis showed that biomarker-negative patients had significantly higher DFS than biomarker- positive patients (risk ratio 1.56, 95% CI, 1.14 - 2.15; P=0.0062). In serial-bleeds (pretreatment, mos 1 and 3) analysis of 214 patients, biomarker-negative patients had significantly higher OS than patients with 1–2 positive- or 3 positive-biomarkers (risk ratio 2.37, 95% CI 1.14 - 4.94, P=0.021; and risk ratio 2.90, 95% CI 1.28 - 6.53, P=0.01, respectively). Multivariate analysis confirmed that 1–2 positive- and 3 positive-biomarkers were significant independent prognostic factors for poor OS (risk ratio 2.44, 95% CI 1.16 - 5.12, P=0.019; and risk ratio 3.08, 95% CI 1.36 to 6.98, P=0.007, respectively). Conclusions: This prospective multicenter blood biomarker validation study demonstrates that multimarker qRT-PCR analysis of CTC has significant clinical utility as a prognostic factor of disease outcome at pretreatment, and as a treatment monitoring prognostic factor in stage IV melanoma patients. No significant financial relationships to disclose.

Preliminary results of G versus GViElC: A phase III trial of gemcitabine associated to vindesine or gemcitabine alone in elderly or poor performance patients with advanced non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 17083-17083
Author(s):  
A. Santo ◽  
G. Genestreti ◽  
A. Terzi ◽  
P. Azzoni ◽  
O. Caffo ◽  
...  
Keyword(s):  
Overall Survival ◽  
Interim Analysis ◽  
Standard Treatment ◽  
Stage Iv ◽  
Poor Performance ◽  
Stage Iiib ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Ecog Ps ◽  
To Receive

17083 Background: Monochemotherapy with gemcitabine (GEM) or vinorelbine is considered the standard treatment in elderly or poor performance (PS) patients (pts) with advanced NSCLC. Many topics report a synergic enhancement of antitumor effect of GEM if associated to Vindesine (VDS). The aim of this study is to evaluate if GEM combined to VDS produces an advantage in terms of overall survival (OS) compared to GEM alone without enhancement of toxicity. Methods: Chemonaive pts with stage IIIB/IV NSCLC, aged ≥ 70 years with PS < 2 or aged < 70 years with PS > 2 were enrolled. Pts were randomized to receive either GEM 1200 mg/m2 day 1 and 8 every 21 days for three cycles (arm 1) or GEM 1000 mg/m2 and VDS 3 mg/m2 (max dose 5 mg) both drugs infused on day 1 and 8 every 21 days for three cycles (arm 2). Pts of both arms received other three cycles in case of responsive or stable disease. Overall survival (OS) was the primary end-point, secondary end-points were time-to-progression and toxicity. First interim analysis was planned at 120 pts enrolled. Results: From May 2002 to December 2005, 107 pts from 13 Italian institutions were enrolled. Their characteristics are: 24 stage IIIB and 83 stage IV, 79 pts with ≥ 70 years (ECOG PS 0–1) and 28 pts with < 70 years (ECOG PS > 2). In arm 1 there were enrolled 55 pts while 52 pts in arm 2: both arms were well balanced with pts characteristics. Conclusions: The enrollment of this phase III trial is ongoing: we are achieving first step for an interim analysis to assess if GEM associated to VDS produces an advantage in terms of OS compared to standard treatment as GEM in monochemotherapy without toxicity enhancement. (Supported by GIVOP: Gruppo Interdisciplinare Veronese di Oncologia Polmonare). No significant financial relationships to disclose.

scholarly journals A survival mediation model with Bayesian model averaging

2021 ◽  
pp. 096228022110370
Author(s):  
Jie Zhou ◽  
Xun Jiang ◽  
Hong Amy Xia ◽  
Peng Wei ◽  
Brian P Hobbs
Keyword(s):  
Bayesian Model ◽  
Bayesian Model Averaging ◽  
Tumor Response ◽  
Model Misspecification ◽  
Model Averaging ◽  
Hematologic Malignancies ◽  
Phase Iii ◽  
Phase Ii Trials ◽  
Novel Therapy ◽  
Phase Iii Trial

Determining the extent to which a patient is benefiting from cancer therapy is challenging. Criteria for quantifying the extent of “tumor response” observed within a few cycles of treatment have been established for various types of solids as well as hematologic malignancies. These measures comprise the primary endpoints of phase II trials. Regulatory approvals of new cancer therapies, however, are usually contingent upon the demonstration of superior overall survival with randomized evidence acquired with a phase III trial comparing the novel therapy to an appropriate standard of care treatment. With nearly two-thirds of phase III oncology trials failing to achieve statistically significant results, researchers continue to refine and propose new surrogate endpoints. This article presents a Bayesian framework for studying relationships among treatment, patient subgroups, tumor response, and survival. Combining classical components of a mediation analysis with Bayesian model averaging, the methodology is robust to model misspecification among various possible relationships among the observable entities. A posterior inference is demonstrated via an application to a randomized controlled phase III trial in metastatic colorectal cancer. Moreover, the article details posterior predictive distributions of survival and statistical metrics for quantifying the extent of direct and indirect, or tumor response mediated treatment effects.

A large first-line, randomized, dose-finding, phase II study on thymosin-alpha 1 (T-alpha 1) plus dacarbazine (DTIC) with or without interferon-alpha (IFN-alpha) compared to DTIC plus IFN-alpha in stage IV melanoma. Tumor response and survival results

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8535-8535 ◽  
Author(s):  
R. Camerini ◽  
A. Mackiewicz ◽  
A. Testori ◽  
U. Trefzer ◽  
J. Jassem ◽  
...  
Keyword(s):  
T Cell ◽  
Null Hypothesis ◽  
Tumor Response ◽  
Stage Iv ◽  
Control Group ◽  
First Line ◽  
Ifn Alpha ◽  
Thymosin Alpha 1 ◽  
Melanoma Patients ◽  
Stage Iv Melanoma

8535 Background: Thymosin alpha 1 is an immunomodulatory compound that promotes T cell maturation and upregulates T cell response. Ta1 showed clinical potential benefit in a previous pilot study in melanoma patients. Methods: Phase II, randomized, stratified, open-study testing different doses of Ta1 in association with DTIC and IFNa, as first-line therapy in stage IV melanoma patients (AJCC 2001) without brain metastases. The primary endpoint is tumor response and secondary overall survival. Four arms were initially planned: DTIC + IFNa + 1.6 or 3.2 mg Ta1, DTIC + 3.2 mg Ta1, and DTIC + IFNa (control group). A dose-response effect in a preliminary analysis on 142 patients led to the addition of a fifth arm with DTIC + IFNa + 6.4 mg Ta1. Ninety-five patients were allocated to each arm to test the hypothesis that P0 = 0.05 vs the alternative hypothesis that P1 = 0.15 (alpha = 5%, within-group statistical analysis, power = 95%). The five groups were analyzed independently one from the other, nine responses representing the minimal threshold for rejecting the null hypothesis Patients received DTIC (800 mg/m2) iv on day 1, Ta1 (1.6, 3.2 or 6.4 mg) sc on days 8–11 and 15–18, and IFNa (3 MIU) sc on days 11 and 18 during 28d cycles. Tumor response was evaluated every two cycles according to RECIST criteria, utilizing a central review. Results: Data of 483 pts (62% M1c; 25% M1b; 13% M1a) from 64 European sites are given in the table . Thirteen and 10 confirmed responses were observed for the DTIC+ 3.2 mg Ta1 and DTIC+ IFNa + 3.2 mg Ta1 arms (vs 5 in the control group) thus rejecting the null hypothesis that P0 = 0.05. No additional toxicity with the addition of Ta1 was observed. Conclusions: These results suggest a potential survival advantage with the addition of Ta1 to ‘standard‘ treatment of stage IV melanoma patients. The role of Interferon alpha in this therapeutic association is debatable. [Table: see text] [Table: see text]

Efficacy and cost of nab-paclitaxel (nab-P) in metastatic melanoma (mM).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20033-e20033
Author(s):  
Sanjiv S Agarwala ◽  
Scott Whiting ◽  
Gary Binder ◽  
Evan Hersh
Keyword(s):  
Statistical Significance ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Drug Infusion ◽  
Phase Iii Trial ◽  
Common Grade ◽  
Full Analysis ◽  
Grade 3 ◽  
Intent To Treat

e20033 Background: A recent phase III trial of nab-paclitaxel (nab-P, 130 nm albumin-bound paclitaxel) vs dacarbazine (DTIC) in mM demonstrated a significant improvement in progression-free survival (PFS). An economic analysis was applied to the results of this trial. Methods: Chemotherapy naive stage IV mM patients received nab-P 150 mg/m2 on days 1, 8, and 15 every 4 weeks or DTIC 1000 mg/m2 every 3 weeks. 529 patients were randomized to nab-P (n = 264) or DTIC (n = 265). The primary endpoint was independently assessed PFS, with overall survival (OS) as a secondary endpoint. Costs of nab-P and DTIC were taken from published 2013 Medicare reimbursement rates. A literature review identified costs for expected adverse events (AE), administration, and recently approved mM treatments. Results: In the intent-to-treat population, median PFS was 4.8 and 2.5 months in the nab-P and DTIC arms, respectively (HR: 0.792; P = 0.044). Median OS at the time of an interim analysis was 12.8 months with nab-P and 10.7 months with DTIC (HR: 0.831; P = 0.094; determination of ultimate statistical significance is pending full analysis at study conclusion). The most common grade ≥3 treatment-related AEs were neuropathy (nab-P: 25% vs DTIC: 0%) and neutropenia (nab-P: 20% vs DTIC: 10%). Grade 4 neutropenia rates were similar between arms (nab-P: 3% vs DTIC: 4%). Median time to neuropathy improvement by >1 grade was 28 days. Median treatment duration was 3 months with nab-P vs 2.1 months with DTIC. Incremental costs per patient were $23,359 ($24,663 for nab-P vs $1,304 for DTIC) including drug, infusion, and AE management costs. These costs compare favorably to incremental costs of over $50,000 for newly approved therapies with similar median OS gains vsDTIC. Conclusions: nab-P is the only chemotherapy in a phase III trial to demonstrate a significant and clinically meaningful delay in disease progression over dacarbazine. Total costs are attractive in the context of other agents recently approved for mM. Further analysis is merited when final OS is available. Clinical trial information: NCT00864253.

Carfilzomib, lenalidomide, and dexamethasone (KRd) versus bortezomib, lenalidomide, and dexamethasone (VRd) for initial therapy of newly diagnosed multiple myeloma (NDMM): Results of ENDURANCE (E1A11) phase III trial.

2020 ◽  
Vol 38 (18_suppl) ◽  
pp. LBA3-LBA3 ◽  
Author(s):  
Shaji Kumar ◽  
Susanna J. Jacobus ◽  
Adam D. Cohen ◽  
Matthias Weiss ◽  
Natalie Scott Callander ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Initial Therapy ◽  
Phase Iii ◽  
Phase Ii Trials ◽  
Phase 3 ◽  
Phase Iii Trial ◽  
Free Survival ◽  
Induction Regimen ◽  
To Receive ◽  
Clinical Trial Information

LBA3 Background: Bortezomib (btz) combined with lenalidomide (len) and dexamethasone (dex) (VRd) is a standard initial therapy for NDMM. Carfilzomib (cfz), a next-generation proteasome inhibitor, in combination with len-dex (KRd) has shown higher efficacy in phase II trials. This randomized phase III trial was designed to examine if KRd improves progression free survival (PFS) compared to VRd in NDMM (current results), and whether indefinite maintenance with len improves OS compared with two-year maintenance (to be analyzed once data matures). Methods: Patients (Pts) with NDMM, were randomized to receive VRd or KRd in a 1:1 fashion for 36 weeks followed by a second randomization (1:1) to indefinite versus two years of len maintenance. Pts without del17p, t (14;16), t(14;20), plasma cell leukemia or high-risk GEP70 profile, were enrolled. VRd arm included btz 1.3 mg/m2 on days(d) 1, 4, 8, and 11 (d 1, 8 for cycles 9-12), len 25 mg d 1-14, and dex 40 mg d 1, 2, 4, 5, 8, 9, 11, 12 of a 3-week (wk) cycle for 12 cycles, while pts in the KRd arm received cfz 36 mg/m2 d 1, 2, 8, 9, 15, 16 with len 25 mg daily on d 1-21 and dex 40 mg wkly, in 4 wk cycles for 9 cycles. Maintenance included len 15mg d 1-21 every 4 wks. The study was designed to detect a hazard ratio (HR)=0.75 with 80% power at 1-sided 2.5% alpha and 399 PFS events (progression or death regardless of intervening therapy). Results: The study accrued 1087 pts (VRd=542, KRd=545). The median age was 65y. Treatment, efficacy, and toxicity data are in the table. At the second of 3 planned interim analyses, with PFS HR=1.04 (95% CI, 0.8 to 1.3, p=0.74), futility was met. Median PFS was VRd=34.4m and KRd=34.6m; no differences were seen based on age (<65 or ≥65), presence or absence of t(4;14) or ISS stage. The three-year OS (95% CI) was similar: VRd 84% (80 to 88) and KRd 86% (82 to 89). Conclusions: In this randomized phase 3 trial, KRd did not improve PFS compared with VRd in NDMM. A significantly higher rate of cardio-pulmonary and renal toxicity was observed with KRd, while neuropathy rates were higher with VRd. VRd remains the standard triplet induction regimen in standard and intermediate risk NDMM, and a suitable backbone for 4 drug combinations. Clinical trial information: NCT01863550 . [Table: see text]

Phase III Comparison of Vitespen, an Autologous Tumor-Derived Heat Shock Protein gp96 Peptide Complex Vaccine, With Physician's Choice of Treatment for Stage IV Melanoma: The C-100-21 Study Group

2008 ◽  
Vol 26 (6) ◽  
pp. 955-962 ◽  
Author(s):  
Alessandro Testori ◽  
Jon Richards ◽  
Eric Whitman ◽  
G. Bruce Mann ◽  
Jose Lutzky ◽  
...  
Keyword(s):  
Overall Survival ◽  
Heat Shock ◽  
Heat Shock Protein ◽  
Interleukin 2 ◽  
Stage Iv ◽  
Phase Iii ◽  
Autologous Tumor ◽  
Heat Shock Protein Gp96 ◽  
To Receive ◽  
Stage Iv Melanoma

Purpose To assess the antitumor activity of vitespen (autologous, tumor- derived heat shock protein gp96 peptide complexes) by determining whether patients with stage IV melanoma treated with vitespen experienced longer overall survival than patients treated with physician's choice. Patients and Methods Patients (N = 322) were randomly assigned 2:1 to receive vitespen or physician's choice (PC) of a treatment containing one or more of the following: dacarbazine, temozolomide, interleukin-2, or complete tumor resection. This open-label trial was conducted at 71 centers worldwide. Patients were monitored for safety and overall survival. Results Therapy with vitespen is devoid of significant toxicity. Patients randomly assigned to the vitespen arm received variable number of injections (range, 0 to 87; median, 6) in part because of the autologous nature of vitespen therapy. Intention-to-treat analysis showed that overall survival in the vitespen arm is statistically indistinguishable from that in the PC arm. Exploratory landmark analyses show that patients in the M1a and M1b substages receiving a larger number of vitespen immunizations survived longer than those receiving fewer such treatments. Such difference was not detected for substage M1c patients. Conclusion These results are consistent with the immunologic mechanism of action of vitespen, indicating delayed onset of clinical activity after exposure to the vaccine. The results suggest patients with M1a and M1b disease who are able to receive 10 or more doses of vitespen as the candidate population for a confirmatory study.

Model-based predictions of expected anti-tumor response and survival in phase III studies based on phase II data of an investigational agent

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6025-6025 ◽  
Author(s):  
L. Claret ◽  
P. Girard ◽  
J. O’shaughnessy ◽  
P. Hoff ◽  
E. Van Cutsem ◽  
...  
Keyword(s):  
Survival Time ◽  
Clinical Response ◽  
Phase Ii ◽  
Tumor Size ◽  
Tumor Response ◽  
Survival Model ◽  
Phase Iii ◽  
Alternative Methods ◽  
Phase Ii Trials ◽  
Phase Iii Studies

6025 Background: Decision making during early oncology drug development remains very empirical. A drug-disease simulation model to predict expected clinical response and survival in phase III studies from observed longitudinal tumor size in phase II trials offers a science-based alternative. Methods: We developed the following: 1) longitudinal exposure-response models of drug effect (and resistance) on tumor growth dynamics based on phase II data on capecitabine (X) in metastatic breast (MBC) and colorectal cancer (MCRC) and on historical phase III data on docetaxel (T) in MBC and 5-FU in MCRC; and 2) a survival model relating change in tumor size and patient characteristics to survival time in MBC and MCRC based on phase III data. The models were validated and used to predict expected anti-tumor response and survival in phase III studies of XT vs. T alone in MBC and X vs. 5-FU in MCRC. Multiple replicates (n = 1000) of simulated phase III studies were compared to actual results. Results: Change of tumor size and survival time distributions in X arms were well predicted. In MBC, expected median (90% prediction interval) survival for patients treated with XT was 412 (range 330 to 526) days (vs. 431 days observed) with an improvement over T of 57 days (range -17 to 148) (vs. 78 days observed). For MCRC patients, X treatment resulted in a potential survival improvement of 39 (range -21 to 110) days (vs. 35 days observed) compared to patients treated with 5-FU. Conclusions: The dose-tumor size-survival model succeeded in predicting survival in phase III trials based on X phase II data in MBC (in combination with T) and as a single agent in MCRC. This model is a useful tool to compare expected clinical response of new compounds to various competitors and to support end-of-phase II decisions and design of phase III studies. [Table: see text]

scholarly journals 591 Survival rates in Stage IV melanoma patients treated with radiation and immunotherapy differ depending on age and radiation treatment site

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A621-A621
Author(s):  
Catherine Colonna ◽  
Nasreen Vohra ◽  
Aiden Burke ◽  
Matthew Peach ◽  
Andrew Ju
Keyword(s):  
Tumor Response ◽  
Radiation Treatment ◽  
Stage Iv ◽  
Rate Of Change ◽  
Abscopal Effect ◽  
Survival Times ◽  
Younger Patients ◽  
Lower Survival ◽  
Melanoma Patients ◽  
Stage Iv Melanoma

BackgroundMelanoma is difficult to treat due to its propensity of evading the immune system. Radiation can be combined with immune checkpoint inhibitors to potentially prolong survival. Radiation has been shown to reduce tumor sizes both at the site of radiation and at non-irradiated lesions, also known as the abscopal effect. However, the interaction of immunotherapy and radiation treatment in melanoma cancer is not well-defined. This study seeks to better characterize factors influencing survival in Stage IV melanoma patients treated with both radiation and immunotherapy.MethodsRetrospective data was collected from melanoma patients receiving both radiation and immunotherapy within 6 months of each other between 2008–2021 at our institution. Patient and treatment characteristics were examined for their influence on overall survival and progression-free survival using the log-rank test on Kaplan Meier survival curves. Radiographic response was assessed according to PERCIST/RECIST criteria and analyzed against patient/treatment characteristics using the Mann-Whitney U Test. For the abscopal effect, the percent changes both before and after radiation treatment were subtracted in non-irradiated lesions to produce a ”delta-delta” percent change to reflect the rate of change in tumor response to radiation treatment.ResultsYounger patients trended towards worse overall (p=0.141) and progression free (p=0.06) survival as well as less favorable PERCIST/RECIST response to radiation (p=.0562) compared to older patients. Combination CTLA-4 and PD-1 inhibition therapy tended to produce better PERCIST/RECIST tumor response (p=0.09), but it did not significantly affect survival times. In addition, there was some lower overall (p=0.22) and significantly lower progression free (p=0.012) survival among patients with intracranial irradiated lesions. However, no difference was found in PERCIST/RECIST response in the irradiated lesions between the intra- or extracranial groups. Non-irradiated lesions in patients with extracranial irradiated lesions had a pattern of less favorable rate of change in tumor size (p=0.16).ConclusionsLower survival times in younger patients is unexpected and may reflect differences in immunotherapy response in patients receiving both radiotherapy and immunotherapy, which requires further investigation. Combination CTLA-4 and PD-1 inhibition therapy correlating with better tumor response confirms the effect is still present in this cohort receiving radiotherapy. The lower survival times among intracranial lesion patients is most likely due to lower expectancy of brain metastasized patients; however, it could also be the brain is less responsive to immunotherapy. Further research in a larger cohort is needed for deeper analysis, but this series is still comparable in size to other published series.Ethics ApprovalThis retrospective review was approved by the University IRB, UMCIRB 15-001726. Consent of participants was waived due to the retrospective nature of this review.

Sign in / Sign up

Export Citation Format

Share Document