scholarly journals Thromboembolism in Patients with Advanced Solid Tumors Treated with Immunotherapy Compared with Platinum-Based Chemotherapy

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1057-1057
Author(s):  
Satish Maharaj ◽  
Ruobing Xue ◽  
Anuja Abhyankar ◽  
Simone M Chang ◽  
Rebecca A. Redman ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Real World ◽  
Cumulative Incidence ◽  
Stage Iv ◽  
Stage Iii ◽  
Advanced Solid Tumors ◽  
Durable Response ◽  
Vein Thrombosis ◽  
Platinum Based Chemotherapy

Abstract Background: Venous and arterial thromboembolism (VTE/ATE) in patients with cancer are a significant cause of morbidity and mortality. Platinum-based chemotherapy (Platinum) has been associated with increased risk of VTE and ATE. In the last decade immunotherapy (IO) has emerged as first line treatment for many patients, alone or in combination with Platinum. Immune checkpoint inhibition can lead to a systemic proinflammatory state with some suggesting an associated procoagulant effect. A systematic review of studies on IO in advanced cancer reported incidence of 2.7% VTE and 1.1% ATE (n=20,273, Solinas et al 2020), concluding ATE/VTE is relatively rare with IO. However, emerging real world data suggest a higher incidence of thrombosis than initially reported, and how VTE/ATE incidence compares with IO as compared with Platinum remains unknown. Methods: We conducted a retrospective cohort study of consecutive patients with advanced solid tumors including non-small cell lung cancer (NSCLC, unresectable Stage III or Stage IV), melanoma (Stage III or Stage IV) and gastrointestinal cancers (Stage IV) during the period 2014-2020 at the Brown Cancer Center. Patients with thrombophilia, anticoagulation use, >1 malignancy, and use of regimens without IO/Platinum were excluded. Treatments included IO, Platinum (cisplatin, carboplatin, oxaliplatin) or combined IO-Platinum. VTE was defined as deep vein thrombosis, pulmonary embolism or visceral vein thrombosis. ATE was defined as any arterial thromboembolic event including arterial stroke, myocardial infarction, peripheral arterial thrombosis and visceral arterial thromboses. The primary outcomes of the study were cumulative incidence rates of VTE and ATE with events recorded in time from diagnosis. Cumulative incidence analyses were performed to compare rates of VTE and ATE for the different modalities of treatment (IO, IO-Platinum, Platinum). Results: A total of 357 patients were included. Clinical characteristics are presented in Table 1 - just over half were male, median age 59 yrs and predominant history of smoking. NSCLC was most represented (41%) followed by GI cancer (34%) and melanoma (25%). Treatment modalities were fairly distributed : IO (34%), IO-Platinum (30%) and Platinum (36%). Over a median follow up of 2.5 yrs, VTE occurred in 80 patients (22%), most commonly PE followed by DVT and VVT (Table 2). At median follow up, the cumulative incidence of VTE with IO was 15.1% [95% CI (9.3-24.6)] vs. IO-Platinum at 23.2% [95% CI (15.1-35.7)] and Platinum at 29.2% [95% CI (21.7-39.4)]. ATE occurred in 25 patients overall (7%) (Table 2). At median follow up, cumulative incidence of ATE with IO was 3.3% [95% CI (1.3-8.7)] vs. IO-Platinum at 7.0% [95% CI (2.5-19.4)] and Platinum at 9.9% [95% CI (5.6-17.6)]. Cumulative incidence frequencies for VTE/ATE are presented graphically according to each treatment modality (Figure). Conclusion: In this cohort of patients, increased incidence of VTE/ATE over time was seen following immunotherapy alone or combined with platinum-based chemotherapy. Immunotherapy can induce a durable response with unprecedented survival benefits and patients with advanced solid tumors are at risk for increasingly longer periods. The reasons behind increased real world incidence relative to historical adverse event reporting are likely multifactorial and further research in larger cohorts is needed. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

Comprehensive real-world evidence research in stage III and IV melanoma: Evaluation of a cohort of patients treated at a Portuguese institution.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18774-e18774
Author(s):  
Ivo Julião ◽  
Jose Luis Cunha ◽  
Patricia Redondo ◽  
Jessica Rodrigues ◽  
Tiago Figueiredo ◽  
...  
Keyword(s):  
Real World ◽  
Clinical Characteristics ◽  
Index Date ◽  
Systemic Treatment ◽  
Stage Iv ◽  
Stage Iii ◽  
Line Treatment ◽  
Adequate Treatment ◽  
Real World Evidence

e18774 Background: Malignant melanoma (MM) is one of the most aggressive skin cancers and its incidence has been increasing worldwide. Deep understanding of patient characteristics and the course of the disease, specially through the evaluation of real-world evidence, is extremely relevant for an adequate treatment approach and better outcomes. This study aims to comprehensively evaluate demographic and clinical characteristics and also treatment outcomes of patients with stage III and IV MM, treated at a Portuguese institution. Methods: Retrospective cohort study of patients with de novo MM stage III/IV or that evolved from earlier MM stages, between 2015 and 2017 (considered the index date). Patients were followed until 12/31/2019. Demographic, clinical and treatment characteristics were evaluated. Survival was assessed, from the index date, using the Kaplan Meier method and log-rank test to compare groups. Results: We included 215 patients with a median age of 66 years (20-96) and 50.2% (n = 108) were male. At index date, 63.7% (n = 137) were stage III. From those, 41.6% (n = 57) progressed to stage IV during follow-up. At diagnosis, the majority of patients had ulceration (53.3%; n = 119), normal LDH ( < 248 U/L; 56.3%; n = 121) and from 110 patients tested for BRAF, 45.4% (n = 50) had a mutation. In earlier stages, 41.8% (n = 81) performed sentinel LN only and from those 61.7% (n = 50) had latter metastatic disease. Complete LND was performed in 49% (n = 95) and 58.9% (n = 56) had a distant relapse. Brain metastasis were diagnosed in 28.4% (n = 61) of the patients, and 50.8% (n = 31) were not eligible for any treatment due to poor clinical status. Systemic treatment was performed in 70 patients with advanced disease. In 1st line, 34 (48.6%) patients underwent anti-PD-1, 28 (40.0%) BRAF/MEKi, 5 (7.1%) BRAFi and 3 (4.3%) chemotherapy. A 2nd line treatment was performed in 21 (30.0%) patients and 2 (9.5%) underwent 3rd line treatment. With a median follow-up of 29 months OS for all patients at 24 months was 54.9% (95% CI; 48.6-62.0): 69.3% (95% CI; 62.0-77.5) for stage III patients and 29.5% (95% CI; 20.9-41.6) for stage IV patients. OS was worst for known risk factors (ulceration, mitotic rate and LDH). OS at 24 months for patients under systemic treatment was 37.4% (95% CI; 26.9-52.0), with no differences between immunotherapy and targeted therapy. Finally, 22 patients were submitted to limb perfusion with an OS of 58.1% (95% CI; 41.2-81.9) at 24 months and a median PFS of 7.4 months (95% CI; 3.9-11.3). Conclusions: Analysis of real-world data is a solid tool in the evaluation, development and improvement of treatment strategies. Demographic and clinical characteristics are comparable to those of other studied cohorts. Longer follow-up of this population and the inclusion of new patients submitted to contemporary approaches will allow improving knowledge and care for melanoma patients in Portugal.

265 Phase 1b study of avelumab + M9241 (NHS-IL12) in patients with advanced solid tumors: interim analysis results from a urothelial carcinoma (UC) dose-expansion cohort

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A291-A291
Author(s):  
Jean-Laurent Deville ◽  
Alain Ravaud ◽  
Marco Maruzzo ◽  
Theodore Gourdin ◽  
Michele Maio ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Solid Tumors ◽  
Dose Escalation ◽  
Interim Analysis ◽  
Maintenance Treatment ◽  
Advanced Solid Tumors ◽  
First Line ◽  
Platinum Based Chemotherapy ◽  
Phase 1B ◽  
Expansion Cohort

BackgroundAvelumab is an anti–PD-L1 monoclonal antibody approved for the treatment of advanced UC after disease progression during or following platinum-based chemotherapy and as maintenance treatment in patients whose disease has not progressed with first-line platinum-based chemotherapy.1–3 M9241 is an immunocytokine composed of 2 heterodimers of IL-12 fused to the heavy chains of a human antibody targeting DNA released from necrotic tumor cells.4 During dose-escalation, avelumab + M9241 was well tolerated and showed promising antitumor activity in patients with advanced solid tumors, including 2 objective responses in patients with UC.5 We report on an interim analysis of efficacy and safety from the dose-expansion part of JAVELIN IL-12 (NCT02994953).MethodsEligible patients had locally advanced or metastatic UC that had progressed on first-line therapy, were aged =18 years, had an Eastern Cooperative Oncology Group performance status of 0/1, and were immune checkpoint inhibitor naive. Patients received the recommended phase 2 dose5 of avelumab 800 mg intravenously once weekly (QW) in combination with M9241 16.8 µg/kg subcutaneously Q4W for the first 12 weeks, then continued the combination with avelumab Q2W. The primary endpoints were confirmed best overall response (BOR) per investigator assessment (RECIST 1.1) and safety. The expansion cohort followed a 2-stage design. During stage 1 (single-arm part of the study), 16 patients were enrolled and treated. A futility analysis based on BOR was planned to determine if stage 2 (randomized controlled part of the study) would be initiated.ResultsAt data cut-off (Jun 3, 2020), 16 patients had received avelumab + M9241 for a median duration of 8 weeks (range, 4.0–25.0 weeks). No complete or partial responses were observed; the study failed to meet the criterion (>2 responders) to initiate stage 2. Two patients (12.5%) had stable disease, 13 (81.3%) had progressive disease, and 1 (6.3%) was not evaluable. Any-grade treatment-related adverse events (TRAEs) occurred in 15 patients (93.8%); the most common (in =4 patients) were pyrexia (50.0%), nausea (37.5%), asthenia (31.3%), anemia (25.0%), and hyperthermia (25.0%); grade 4 gamma-glutamyltransferase increased occurred in 1 patient (6.3%). No TRAEs led to death. Pharmacodynamic effects on the peripheral immune system and results of pharmacokinetic and biomarker analyses will also be reported.ConclusionsThe predefined efficacy criterion to proceed to stage 2 was not met. The combination was well tolerated; no new safety signals emerged and the profile was consistent with the dose-escalation part of the study.5Trial RegistrationNCT02994953Ethics ApprovalThe study was approved by each site’s independent ethics committee.ConsentN/AReferencesBavencio(avelumab) injection [package insert]. Rockland, MA: EMD Serono, Inc; New York, NY: Pfizer Inc; 2020.Health Canada. https://www.canada.ca/en/health-canada.html. Accessed July 31, 2020.US Food and Drug Administration. FDA approves avelumab for urothelial carcinoma maintenance treatment. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-avelumab-urothelial-carcinoma-maintenance-treatment. Accessed July 31, 2020.Fallon J, Tighe R, Kradjian G, et al. The immunocytokine NHS-IL12 as a potential cancer therapeutic. Oncotarget. 2014;5:1869–1884.Strauss J, Vugmeyster Y, Sznol M, et al. Phase 1b, open-label, dose escalation study of M9241 (NHS-IL12) plus avelumab in patients (pts) with advanced solid tumours. Ann Oncol. 2019;30(5 Suppl):Abstract 4062.

Arthroscopic Treatment of Anterior Ankle Impingement

1997 ◽  
Vol 18 (7) ◽  
pp. 418-423 ◽  
Author(s):  
Alberto Branca ◽  
Luigi Di Palma ◽  
Carmelo Bucca ◽  
Camilla Sagarriga Visconti ◽  
M. Di Mille
Keyword(s):  
Preoperative Evaluation ◽  
Stage Iv ◽  
Ankle Arthroscopy ◽  
Stage Iii ◽  
Joint Cartilage ◽  
Ankle Impingement ◽  
Radiological Classification ◽  
Invasive Techniques ◽  
Anterior Ankle Impingement

Ankle arthroscopy has recently allowed the elaboration of less invasive techniques for the treatment of anterior impingement. Its indications, advantages, and drawbacks in this application are discussed. Between 1987 and 1994, 133 patients were treated for ankle impingement. Among them, 58 patients, 37 men and 21 women (mean age, 28.5 years), who had failed a trial of conservative treatment were treated by means of tibiotalar arthroscopy. Twenty-seven were athletes engaged in sports with abnormal stressing of the ankle. According to McDermott's radiological classification, there were 15 stage I cases, 23 stage II, 13 stage III, and 7 stage IV. Preoperative evaluation with a modified version of McGuire's scoring system gave 50 cases rated as “poor” (<60 points) and 8 cases rated as “fair” (60–67 points). Treatment consisted of removal of adhesions, cartilage shaving, and removal of the bone impingement with powered instruments, curettes, or small osteotomes. Follow-up was from 8 to 62 months (mean, 21.5 months). The postoperative McGuire ratings were 37 good, 13 fair, and 8 poor. There were no major complications. Recurrence of impingement was observed in four cases of stage III and IV. The conclusion is drawn that ankle arthroscopy is a sound method for the treatment of anterior impingement. Even in cases with severe joint cartilage impairment, it plays a therapeutic role as a means of postponing a possible arthrodesis.

scholarly journals Cumulative Incidence and Predictors of CNS Metastasis for Patients With American Joint Committee on Cancer 8th Edition Stage III Melanoma

2020 ◽  
Vol 38 (13) ◽  
pp. 1429-1441 ◽  
Author(s):  
Lauren E. Haydu ◽  
Serigne N. Lo ◽  
Jennifer L. McQuade ◽  
Rodabe N. Amaria ◽  
Jennifer Wargo ◽  
...  
Keyword(s):  
Primary Tumor ◽  
Cumulative Incidence ◽  
Mitotic Rate ◽  
Stage Iii ◽  
Time Points ◽  
Cns Metastasis ◽  
American Joint Committee ◽  
Stage Iii Melanoma ◽  
8Th Edition

PURPOSE Improved understanding of the incidence, risk factors, and timing of CNS metastasis is needed to inform surveillance strategies for patients with melanoma. PATIENTS AND METHODS Clinical data were extracted from the databases of 2 major melanoma centers in the United States and Australia for 1,918 patients with American Joint Committee on Cancer (AJCC) 8th edition stage III melanoma, diagnosed from 1998-2014, who had (negative) baseline CNS imaging within 4 months of diagnosis. The cumulative incidence of CNS metastasis was calculated in the presence of the competing risk of death, from stage III presentation and at benchmark time points 1, 2, and 5 years postdiagnosis. RESULTS At a median follow-up of 70.2 months, distant recurrence occurred in 711 patients (37.1%). The first site of distant metastasis was CNS only for 3.9% of patients, CNS and extracranial (EC) for 1.8%, and EC only for 31.4%. Overall, 16.7% of patients were diagnosed with CNS metastasis during follow-up. The cumulative incidence of CNS metastasis was 3.6% (95% CI, 2.9% to 4.6%) at 1 year, 9.6% (95% CI, 8.3% to 11.0%) at 2 years, and 15.8% (95% CI, 14.1% to 17.6%) at 5 years. The risk of CNS metastasis was significantly influenced by patient sex, age, AJCC stage, primary tumor site, and primary tumor mitotic rate in multivariable and conditional analyses. High primary tumor mitotic rate was significantly associated with increased risk of CNS metastasis at diagnosis and all subsequent time points examined. CONCLUSION Similar rates of CNS metastasis were observed in 2 large, geographically distinct cohorts of patients with stage III melanoma. The results highlight the importance of primary tumor mitotic rate. Furthermore, they provide a framework for developing evidence-based surveillance strategies and evaluating the impact of contemporary adjuvant therapies on the risk of CNS metastasis development.

Characteristics of stage III and IV M0 prostate cancer (PCa) patients in SEER-Medicare who develop bone metastasis (BM) following diagnosis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15146-e15146
Author(s):  
Arif Hussain ◽  
Ebere Onukwugha ◽  
Jinani Jayasekera ◽  
Diane L. McNally ◽  
Brian S. Seal ◽  
...  
Keyword(s):  
Stage Iv ◽  
Patient Characteristics ◽  
Stage Iii ◽  
Age Group ◽  
Diagnosis Code ◽  
Exclusion Criteria ◽  
Chi Square ◽  
Medicare Database ◽  
Stage Stage

e15146 Background: BM is diagnosed in 70-80% of men with metastatic PCa. Less is known about the timing of BM diagnosis following incident non-metastatic PCa and associated patient characteristics. In this study, we determined the incidence and timing of post-diagnosis BM (BMpd) among PCa patients (pts) by incident stage, age, race and year of diagnosis using a large observational dataset. Methods: We analyzed pts aged 66 or older from the linked Surveillance, Epidemiology, and End Results and Medicare (SEER-Medicare) database. Pts with PCa were identified between 2000 and 2007 and were followed until death, Medicare disenrollment, HMO enrollment, or end of the study (December 31, 2009). The cohort included incident stage III and IV(M0) PCa in SEER, and identified BM occurring either within (i.e., +/-) 1 month of the SEER diagnosis month (BM90) or beyond the initial 90-day window (BMgt90) based on the presence of at least one inpatient or one outpatient claim with a diagnosis code of 198.5. We calculated summary and chi-square statistics to examine BMpd, BM90, and BMgt90 by incident stage, age, race and year of PCa diagnosis. Results: Among 9,188 Stage III (72%) and IV(M0) (28%) PCa pts who met inclusion/exclusion criteria, 14.6% (n=1,345) had BMpd: 2.3% (n= 217) had BM90 and 12.3% (n=1,128) had BMgt90. Average age was 72 years and 9% were African American (AA). Incidence of BMpd varied by stage (stage III: 11%; stage IV/M0: 25%; p<0.001) and by age group (66-74 years: 13%; 75-84 years: 19%; >85 years: 22%; p<0.001) but not by race (White: 15%; AA: 16%; Other: 13%; p=0.49). The diagnosis BM90 and BMgt90 varied with stage (stage III: 2% and 9%; stage IV(M0): 4% and 21%; p<0.0001) and age (66-74 years: 2% and 11%; 75-84 years: 3% and 16%; >85 years: 5% and 17%; p<0.001). The incidence of BM decreased over time whether considering BMpd (19% in 2000 to 9% in 2007; p<0.001), BM90 (4% in 2000 to 2% in 2007; p=0.03) or BMgt90 (16% in 2000 to 6% in 2007; p<0.001). Conclusions: BM occurred in only 2% of incident stage III/IV(M0) PCa pts within 1 month of diagnosis, but nearly 15% were diagnosed with BM during a median follow-up of 57 months. Prevalence of BM was highest in stage IV(M0) and older pts.

Accelerated hypofractionated hemithoracic intensity modulated radiation therapy (IMRT) followed by extrapleural pneumonectomy (EPP) for malignant pleural mesothelioma (MPM): Results of a phase I/II study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7526-7526
Author(s):  
Marc de Perrot ◽  
Ronald Feld ◽  
Natasha B. Leighl ◽  
Isabelle Opitz ◽  
Masaki Anraku ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Stage Iv ◽  
Stage Iii ◽  
Extrapleural Pneumonectomy ◽  
Final Pathology ◽  
Concomitant Boost ◽  
Short Period ◽  
Disease Free

7526 Background: We developed a protocol with accelerated hypofractionated hemithoracic IMRT followed by EPP for MPM. Advantages include optimal delivery of radiation to the whole tumor bed in a short period limiting the risk of viable tumor cell spread during surgery. Methods: Patients with resectable clinical T1-3N0M0 histology proven MPM were eligible for the study. 25 Gy in 5 daily fractions over 1 week was delivered to the entire ipsilateral hemithorax by IMRT with concomitant boost of 5 Gy to volumes at high risk based on CT and PET scan findings. EPP was performed one week after the end of radiation. Adjuvant chemotherapy was offered to patients with ypN2 on final pathology. The primary end-point was treatment related mortality. Secondary endpoint included overall survival and disease-free survival (DFS). Initial sites of recurrence were also recorded. Results: Twenty five patients were accrued between 11/2008 and 10/2012. Patients had a median age of 64 years (range, 45-75), 76% were males, 64% had epithelioid histology. All patients completed IMRT and EPP. IMRT was well tolerated with no grade 3-5 toxicity. EPP was performed 6±2 days after completion of IMRT. Surgical complications occurred in 18 patients. One patient died from empyema at 88 days. All but one patient (stage IB) had stage III (n=11) or IV (n=13) disease on final pathology. Five out of 13 patients with ypN2 disease underwent adjuvant chemotherapy. After a median follow-up of 19 months (range, 3-51), the estimated 3-year survival reached 62%. Survival was significantly better in epithelioid compared to biphasic pathologic subtypes (83% survival at 3 years vs 19%, respectively; p=0.004). 14 patients remain disease free after a median follow-up of 17 months (range, 3-37). 2-year DFS was 85% in stage III and 37% in stage IV disease (p=0.03). Recurrences occurred in the ipsilateral chest only (n=2), ipsilateral chest and distant sites (n=2), and distant sites only (n=6). Conclusions: Accelerated hypofractionated hemithoracic IMRT followed by EPP is feasible. This treatment could improve survival in selected patients with epithelial subtype. Clinical trial information: NCT00797719.

The association of toxicities and outcomes with circulating endothelial cells (CEC) in non-small cell lung cancer (NSCLC) patients (pts) treated with bevacizumab (Bev).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19012-e19012
Author(s):  
Nooshin Hashemi Sadraei ◽  
Lingling Du ◽  
Ruchi Yadav ◽  
Ronald Grane ◽  
Barbara Jacobs ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Healthy Subjects ◽  
Proportional Hazards ◽  
Stage Iv ◽  
Stage I ◽  
Circulating Endothelial Cells ◽  
Advanced Solid Tumors ◽  
Chi Square ◽  
Disease Characteristics ◽  
Nsclc Patients

e19012 Background: Bev in combination with chemotherapy (CT) is a standard treatment for pts with stage IV NSCLC. However, there are no established biomarkers to improve benefit-to-risk profile of therapy. CEC are a marker of vascular turnover. We hypothesized CEC may be associated with treatment outcome/toxicity. Methods: Stage IV NSCLC pts were treated with Bev along with CT of choice per clinician. CEC were measured at baseline and after 2 cycles of Bev-containing therapy. CellSearch (Veridex, New Jersey) was used to capture and quantify CEC via immunomagnetic and immunofluorescence techniques. CEC were enumerated as nucleated, CD146+/CD105+/CD45- cells in 4 mL of blood. For comparison, baseline CEC were also collected in 3 other groups; healthy subjects, stage I-III NSCLC, and advanced solid tumor pts. Chi-square tests and non-parametric methods were used to assess associations between CEC and pt/disease characteristics, toxicity, and proportional hazards models were used for comparisons of progression free and overall survival (PFS and OS). Results: Evaluated were 62 individuals: 29 stage IV NSCLC, 10 stage I-III NSCLC, 13 advanced solid tumors (melanoma, sarcoma, renal and adrenal cancers), and 10 healthy subjects. The median of CEC/ml blood in healthy subjects was 6. Based on its distribution, CEC >13/ml was deemed elevated. Elevated CEC was seen in 48% of stage IV NSCLC (median 12/ml), in comparison to 20% of stage I-III NSCLC (8/ml) and 23% of advanced solid tumors (6/ml) Baseline CEC in stage IV NSCLC was independent of patient/ disease characteristics including site of disease and tumor size. CEC increased during treatment in most patients (61%). CEC doubling between baseline and cycle2 was associated with more cytopenia and hemorrhage. (75% vs 20%, p=0.05 and p=0.03 for absolute and relative CEC changes). Baseline CEC and changes during treatment did not correlate with response (p≥ 0.32) and pts with elevated baseline CEC had a trend towards worse PFS (p=0.09) and OS (p=0.10). Conclusions: CEC are commonly elevated in advanced NSCLC. CEC increases may be predictive of adverse events from Bev-CT and when elevated at baseline may suggest worse PFS.

Follow-up of a French national cohort of melanoma stage IV and unresectable stage III patients, MelBase.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. e20113-e20113
Author(s):  
Clara Allayous ◽  
Stephane Dalle ◽  
Philippe Saiag ◽  
Caroline Dutriaux ◽  
Laurent Mortier ◽  
...  
Keyword(s):  
Stage Iv ◽  
Stage Iii ◽  
Unresectable Stage ◽  
National Cohort

Pilot study on outcome and antitumor efficacy of an autologous cancer cell vaccine applied in patients with advanced solid tumors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 3000-3000 ◽  
Author(s):  
Eglys Gonzalez Marcano ◽  
Leona Kröhle ◽  
Joachim Ahlers ◽  
Joachim Drevs
Keyword(s):  
Pilot Study ◽  
Side Effects ◽  
Tumor Marker ◽  
Solid Tumors ◽  
Tumor Cells ◽  
Cell Vaccine ◽  
Advanced Solid Tumors ◽  
Tumor Cell Death ◽  
Informed Consent Form

3000 Background: In the last decade cancer immunotherapy has emerged as the most promising anti-tumor approach. The most commonly used immunotherapies are vaccines and checkpoint inhibitors. An autologous cell vaccine is made with the patient's own tumor cells processed in vitro, which may elicit a cytotoxic T-lymphocytic immune response against tumor cells antigens, resulting in tumor cell death. We performed a pilot study to evaluate the clinical relevance and general outcome of an autologous vaccine as a treatment in different types of cancer. Methods: A total of 31 patients (n=31) with advanced solid tumors and the lack of standard treatments were treated with an immunotherapy protocol consisting of 6 intradermal doses of the vaccine, given the first two doses at day 1 and 2, and the rest every two weeks. All patients signed an informed consent form. Response evaluation was assessed by PET/CT identified as metric (iRECIST) response and in some cases tumor markers where available. Results: Out of 31 patients treated, 2 patients suffered from pancreatic cancer, 2 from sarcoma, 1 from lung cancer, 13 from breast cancer, 2 from ovarian cancer, 1 from prostate cancer, 1 from cholangiocarcinoma, 4 from colorectal cancer, 1 from non-Hodgkin lymphoma, 1 from gastric cancer, 1 from laryngeal and hypopharyngeal cancer, 1 from fallopian tube cancer, 1 from peritoneal cancer. Side effects related to the therapy were rare including light redness in the area of injection and in one case inflammation of the tumor area. 26 patients were evaluated for metric response and 5 for tumor marker response assessment. For tumor marker follow up 9.6 % had a SD of > 3 month and 6.5 % a PD. For metric follow up 12.9 % had a CR, 6.5 % a PR, 25.8 % a SD of > 3 month and 38.7 % a PD. Conclusions: This study have confirmed an anti-tumor response in the majority of patients treated, with none to very low side effects and a good quality of life during the treatment. To obtain more detailed and significant data on the efficacy of this therapy, a further controlled clinical phase study should be performed.

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