Efficacy, rate of tumor response, and safety of a short course (12-24 weeks) of oral vismodegib in various histologic subtypes (infiltrative, nodular, and superficial) of high-risk or locally advanced basal cell carcinoma, in an open-label, prospective case series clinical trial

2020 ◽  
Vol 82 (4) ◽  
pp. 946-954 ◽  
Author(s):  
Scott W. Fosko ◽  
Melinda B. Chu ◽  
Eric Armbrecht ◽  
Tim Galperin ◽  
Geoffrey A. Potts ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Tumor Response ◽  
Locally Advanced ◽  
Case Series ◽  
Efficacy Rate ◽  
Open Label ◽  
Short Course ◽  
Prospective Case Series ◽  
Histologic Subtypes ◽  
Advanced Basal Cell Carcinoma

NACRE: A randomized study comparing short course radiotherapy with radiochemotherapy for locally advanced rectal cancers in the elderly—Preliminary results.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 4-4
Author(s):  
Eric FRANCOIS ◽  
Mandy Pernot ◽  
Philippe Ronchin ◽  
Elodie Nouhaud ◽  
Isabelle Martel Lafay ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Locally Advanced ◽  
The Elderly ◽  
R0 Resection ◽  
Resection Rate ◽  
Logrank Test ◽  
Delayed Surgery ◽  
Short Course ◽  
Short Course Radiotherapy

4 Background: Neoadjuvant therapy followed by total mesorectal surgery is the standard of care for locally advanced rectal carcinoma (RC). In the elderly, often underrepresented in clinical trials, but who represent a very large number of patients, therapeutic proposals are not based on high levels of evidence. The NACRE study investigated the role of short course radiotherapy with delayed surgery in this population. Methods: The PRODIGE 42-GERICO 12 NACRE is a multicenter randomized clinical trial aimed at comparing Arm A preop radiochemotherapy (RCT) (50 Gy, 2Gy/fraction [fr]; 25 fr + capecitabine) and delayed surgery and Arm B short course radiotherapy (25 gy, 5Gy/fr, 5fr) and delayed surgery. Eligible patients (pts) had cT3 or cT4 (or cT2 of the very low rectum), M0 rectal adenocarcinomas <12 cm from the anal verge, age ≥75years, and WHO PS ≤2. Randomization was stratified by center, T (T2/T3-T4) stage and Age (≤80 or >80 years). Two primary end-points will be analyzed according to the hierarchical sequential procedure: firstly R0 resection rate (non-inferiority test with a 8% non-inferiority margin), secondly preservation of autonomy using IADL score (superiority test with 15% absolute difference margin); secondary end-point will be survival and toxicity. We present here the results for R0 resection, survival and toxicities. Results: 29 sites randomized 101 patients from 01/2016 to 08/2019, 59 were males (58.4%), median age was 80 years (range 75-91). Pts characteristics were well balanced. 14% of pts in arm A did not receive all of the planned neoadjuvant treatment compared to 0% in arm B. The R0 resection rate in arm B (86.0% [IC95% 73-94%]) was not-inferior to the R0 resection rate in arm A (89.8% [ic95% 77-97%]), p=0.04 (non inferiority test). With a median follow-up of 15.8 months (CI95%: 14.8-26.0), the 6 months death rate was 10.0% (CI95%: 3.0-22.0) in arm A and 3.92% (CI95%: 0 -13.0) in arm B. There is a significant difference in overall survival between the two arm in favor of arm B (p=0.04, LogRank test), and there is a trend in favor of arm B for specific survival (p=0.06 LogRank test). Disease free survival is not statistically different (p=0.9). 13 serious adverse events were observed in arm A during preoperative phase, 7 in arm B, 16 and 10 respectively during the post-operative phase. Conclusions: These preliminary results show that short course radiotherapy with delayed surgery is associated with better compliance than radiochemotherapy in elderly patients and could give an advantage in overall survival. This regimen may be preferred in elderly patients. Clinical trial information: NCT02551237.

scholarly journals Outcomes of Vismodegib for Periocular Locally Advanced Basal Cell Carcinoma From an Open-label Trial

2020 ◽  
Vol 138 (7) ◽  
pp. 749 ◽  
Author(s):  
Meydan Ben Ishai ◽  
Alon Tiosano ◽  
Eyal Fenig ◽  
Guy Ben Simon ◽  
Iftach Yassur
Keyword(s):  
Basal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Basal Cell ◽  
Locally Advanced ◽  
Open Label ◽  
Open Label Trial ◽  
Advanced Basal Cell Carcinoma

PLATFORM: Planning treatment of oesophago-gastric (OG) cancer—A randomised maintenance therapy trial.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. TPS187-TPS187 ◽  
Author(s):  
Catherine Cafferkey ◽  
Ian Chau ◽  
Fiona Thistlethwaite ◽  
Russell D. Petty ◽  
Naureen Starling ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Maintenance Therapy ◽  
Survival Benefit ◽  
Objective Response ◽  
Locally Advanced ◽  
First Line ◽  
Her2 Positive ◽  
Open Label ◽  
Line Chemotherapy

TPS187 Background: Outcomes for patients with advanced OG cancer remain poor, median overall survival for fit patients treated with platinum and fluoropyrimidine based chemotherapy is less than one year, with second line chemotherapy resulting in a modest (approximately 6 weeks) survival benefit for selected patients. Evidence from NSCLC trials suggests a survival benefit from maintenance treatment following first line chemotherapy. Emerging data also supports the use of immunotherapy in previously treated OG cancer. The PLATFORM study aims to evaluate maintenance therapy in patients with advanced OG cancer. Methods: This is a prospective, open label, multicentre, randomised phase II clinical trial which will recruit at multiple UK cancer centres. Eligible patients are those who have measurable stable disease or better following completion of first line chemotherapy (at least 6 cycles) for locally advanced unresectable or metastatic disease. First line chemotherapy regime should contain a platinum and 5-fluoropyridimine (with trastuzumab if HER2 +), doublet or triplet drug combinations are permitted. Maintenance strategies are split by HER 2 status. For HER2 negative patients these are: Arm A1: surveillance, Arm A2: capecitabine, Arm A3: MEDI 4736 (anti PDL1 inhibitor) and for HER2 positive patients; Arm B1: trastuzumab, Arm B2: in development. Target recruitment is six hundred and sixteen patients, 154 patients will be recruited to each arm, with an interim analysis following recruitment of 61 patients to each arm. An adaptive trial design enables ineffective treatments to be discontinued early, with the opportunity to add novel treatment arms as the trial progresses. Primary endpoint is progression free survival. Secondary endpoints are progression free rate at 3, 6 & 12 months, overall survival, objective response rate by RECIST 1.1, toxicity and analysis of efficacy endpoints according to biomarker status for selected arms. Thirty two patients have been registered for the study with 3 patients randomised, recruitment is ongoing. Clinical trial information: EUDRACT: 2014-002169-30.

scholarly journals Treatment of periocular advanced basal cell carcinoma with Hedgehog pathway inhibitors: a single-center study and a new dedicated therapeutic protocol

2021 ◽  
Author(s):  
Vincenzo De Giorgi ◽  
Luciana Trane ◽  
Giulia Pieretti ◽  
Nicola Santoro ◽  
Flavia Silvestri ◽  
...  
Keyword(s):  
Basal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Basal Cell ◽  
Locally Advanced ◽  
Delayed Diagnosis ◽  
Case Series ◽  
Hedgehog Pathway ◽  
Single Center ◽  
Management Protocol ◽  
Advanced Basal Cell Carcinoma

Background: The management of difficult-to-treat periocular basal cell carcinoma becomes very challenging in cases of delayed diagnosis, leading to the development of locally advanced basal cell carcinoma.Objective: The aim of this study was to evaluate the outcomes of Hedgehog pathway inhibitors (vismodegib and sonidegib)  treatment in patients affected by periocular locally advanced basal cell carcinoma. We focused on the common adverse events  and their correlation with the administration schedule  in order to determine a management protocol specific for the periocular area.Methods:  This observational prospective study included a single-center case series with patients who were histologically confirmed to have periocular or orbital locally advanced basal cell carcinoma,  treated with Hedgehog pathway inhibitors.Results: All patients benefitted in terms of regression or stabilization of the neoplasm. In the first months of treatment, the HPIs were well tolerated, and the first important side effects appeared after about 5 months of continuous use of the drug.Conclusion: These data could lead to a new type of therapeutic scheme where neoadjuvant therapy could be followed by pulse therapy as an adjuvant to surgery.

POWER: An open-label, randomized phase III trial of cisplatin and 5-FU with or without panitumumab (P) for patients (pts) with nonresectable, advanced, or metastatic esophageal squamous cell cancer (ESCC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS4158-TPS4158 ◽  
Author(s):  
Markus Hermann Moehler ◽  
Ingo Ringshausen ◽  
Ralf Hofheinz ◽  
Salah-Eddin Al-Batran ◽  
Lothar Mueller ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Safety Data ◽  
Phase Iii ◽  
Tumor Control ◽  
Open Label ◽  
Phase Iii Trial ◽  
Metastatic Setting

TPS4158 Background: More than 50% of pts with esophageal cancer have locally advanced or metastatic disease at the time of initial diagnosis. For this group chemotherapy is increasingly used intending local and distant tumor control, improvement of quality of life (QoL) and longer survival. Previous data suggested that EGFR-targeting antibodies may be safely combined with cisplatin and 5-FU, and in addition may increase the efficacy of the standard cisplatin/5-FU regimen [Lorenzen et al, Ann Oncol2009; 20(10): 1667-1673]. Methods: In this open-label, randomized (1:1), multicenter, multinational phase III trial pts with nonresectable, advanced or metastatic ESCC, not eligible for definitive radiochemotherapy, are included. Pts have measurable or non-measurable disease according to RECIST 1.1 and an ECOG PS 0-1. Previous chemotherapy of ESCC in the metastatic setting, concurrent radiotherapy involving target lesions and previous exposure to EGFR-targeted therapy are excluded. Pts receive either CTX (cisplatin 100 mg/m² on day 1 and 5-FU 1000 mg/m²/d on day 1-4) or CTX + P (9 mg/kg on day 1). Cycles are repeated every 3 weeks until progression of disease. Tumor assessment is performed every 9 weeks. The primary objective is to demonstrate superiority of CTX + P over CTX alone in terms of overall survival. Secondary endpoints are progression-free survival, 1-year survival, response rate, safety and tolerability, and QoL. A translational analysis in tumor tissue and serum samples is included. 300 pts are planned to be enrolled for a power of 90% to reject the null hypothesis in which the median overall survival in the control and experimental groups are 6 and 9 months, respectively. 18 pts have been enrolled to date. A Data Monitoring Board will review safety data after 40, 100 and 200 pts. The clinical trial registry number is NCT1627379. Clinical trial information: NCT01627379.

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