PCN64 Cost Per Objective Response With Dabrafenib+Trametinib As The First Line Of Treatment In Patients With Unresectable Or Metastatic Melanoma With BRAF V600 Mutation In Colombia

2021 ◽  
Vol 24 ◽  
pp. S31
Author(s):  
M. Díaz-Ortega ◽  
S. Vergara ◽  
E. Montenegro ◽  
D. Barbosa
Keyword(s):  
Metastatic Melanoma ◽  
Objective Response ◽  
First Line ◽  
Braf V600 Mutation

Pegylated liposomal doxorubicin plus paclitaxel as an individualized chemosensitivity-directed treatment in advanced metastatic melanoma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8551-8551
Author(s):  
S. Ugurel ◽  
K. Neuber ◽  
C. Pfoehler ◽  
C. Mauch ◽  
J. Ulrich ◽  
...  
Keyword(s):  
Overall Survival ◽  
Side Effects ◽  
Metastatic Melanoma ◽  
Liposomal Doxorubicin ◽  
Objective Response ◽  
Pegylated Liposomal Doxorubicin ◽  
Study Endpoint ◽  
First Line ◽  
In Vitro Chemosensitivity

8551 Background: Melanoma is a cutaneous neoplasm known for its high agressiveness and its poor prognosis once metastasized. Dacarbacine chemotherapy is actually considered standard first-line treatment of metastatic melanoma, with reported response rates of 6–7%. Due to this unsatisfactory situation, a number of non-standard anti-cancer drugs have been tested for improved efficacy. The present study was aimed to test doxorubicin plus paclitaxel in metastatic melanoma patients based on in-vitro chemosensitivity of this drug combination in fresh tumor samples. Methods: The primary study endpoint was objective response, secondary endpoints were safety and overall survival. Patients with histologically confirmed metastatic melanoma (AJCC stage IV), measurable tumor parameters, and an in-vitro chemosensitivity to doxorubicin plus paclitaxel which is superior to other test drugs determined by an ATP-based luminescence viability assay, were eligible. Patients received paclitaxel 175 mg/m2 i.v. followed by pegylated liposomal doxorubicin 30 mg/m2 i.v. at d1 every 28 days. Tumor assessment was performed every 8 weeks and evaluated according to RECIST. Treatment was continued at a tumor response of stable disease (SD) or better, and stopped in case of disease progression (PD) or intolerable side effects. Results: Out of 14 patients enrolled into this study, 12 received study treatment as first-line, and two as second-line therapy. Objective response was 14.3% (1 CR, 1 PR); progression arrest was 28.6% (1 CR, 1 PR, 2 SD). Median overall survival was 9.7 months. Common slight to moderate side effects were myelosuppression and neurotoxicity. Severe toxicities (CTC grade 3/4) were experienced by three patients (21.4%), with two of them presenting severe myelosuppression, and one experiencing myocardial infarction. Conclusions: Pegylated liposomal doxorubicin combined with paclitaxel shows significant efficacy in advanced metastatic melanoma if applied in an individualized, sensitivity- directed regimen. The observed side effects were comparable to other combination chemotherapies. This treatment regimen needs further evaluation in larger clinical trials containing standard therapy control groups. No significant financial relationships to disclose.

Association of concomitant use of acid reducing agents in full-dose vemurafenib users with risk of progression in BRAF V600 mutation-positive unresectable or metastatic melanoma patients: A retrospective cohort study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9540-9540
Author(s):  
Lotte Marieke Knapen ◽  
Rutger H.T. Koornstra ◽  
Johanna H.M. Driessen ◽  
Bas Van Vlijmen ◽  
Sander Croes ◽  
...  
Keyword(s):  
Cohort Study ◽  
Metastatic Melanoma ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
First Line ◽  
Full Dose ◽  
Reduced Dose ◽  
Increased Risk ◽  
Risk Of Progression ◽  
Braf V600 Mutation

9540 Background: Vemurafenib is used for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. The approved fixed vemurafenib dose of 960 mg twice daily may result in overexposure. Concomitant use of acid reducing agents (ARAs) may result in underexposure. Both situations are likely to affect treatment outcome. Therefore, the aim of this study was to determine the association between the use of vemurafenib (full-dose versus reduced dose) and/or concomitant ARA use (yes versus no) and the risk of disease progression. Methods: A retrospective cohort study was conducted using data from the electronic health record software of the Radboudumc pharmacy and medical records of the Radboudumc (March 17th 2012 to March 17th 2016). Patients (N = 112) using vemurafenib as first line treatment for melanoma were included. Multivariable cox regression estimated adjusted hazard ratios (HRa) and 95% confidence intervals (CI) of progression in vemurafenib users (full-dose N = 67 versus reduced dose N = 45) and/or concomitant ARA users (N = 38). Adjustments were made for age and sex. Results: The mean follow-up time was 3.5 months and 41 patients (36.6%) developed progression on first line vemurafenib. Co-treatment of ARAs in patients using full-dose vemurafenib was associated with a 4.6-fold increased risk of progression (HRa 4.56; 95% CI 1.51-13.75) as compared to full-dose vemurafenib users not co-treated with ARAs. No increased risk was found for users of vemurafenib in a reduced dose, regardless of concomitant ARA use. Conclusions: Concomitant use of ARAs in full-dose vemurafenib users was associated with an increased risk of progression. Physicians should be cautious to prescribe ARAs to patients tolerating full-dose vemurafenib. The presence of considerable confounding by disease severity, the small number of events and the hypothesis generating character of this study emphasize the need to prospective validate these results.

Continuous intravenous infusion Rh-endostatin in combination with dacarbazine and cisplatin as the first-line therapy for metastatic melanoma.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e21007-e21007
Author(s):  
Chuanliang Cui ◽  
BIN LIAN ◽  
Xuan Wang ◽  
Zhihong Chi ◽  
Lu Si ◽  
...  
Keyword(s):  
Continuous Infusion ◽  
Metastatic Melanoma ◽  
Intravenous Infusion ◽  
Objective Response ◽  
Stage Iv ◽  
Advanced Melanoma ◽  
Drug Discontinuation ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

e21007 Background: Immunotherapy and targeted therapy have dramatically improved the survival of advanced melanoma patients (pts), but they show relative lower efficacy in Asian pts especially in acral and mucosal subtypes. Rh-Endostatin (endostar) is a potent endogenous inhibitor of angiogenesis. Previous studies have indicated that endostar combined with dacarbazine (DTIC) was effective in the treatment of metastatic melanoma. To further improve the effectiveness, this study was designed to observe the efficacy and safety of continuous infusion (CIV) of endostar combined with DTIC and cisplatin as the first line therapy for advanced melanoma pts. Methods: Pts with treatment naive, ECOG 0/1, and unresectable stage IIIC or IV melanoma were enrolled. DTIC (250 mg/m2, intravenous infusion, day 1-5), cisplatin (75 mg/m2, intravenous infusion, separated in 3 days) and endostar (15 mg/m2, CIV, day 1-14) were administered in a 28-day cycle until disease progression or intolerable toxicity. The primary endpoint was progression free survival (PFS). Secondary endpoints included disease control rate (DCR) and safety. Results: From January 2016 to May 2018, 64 pts were enrolled and 50 pts were evaluable. 26 pts were female. The median age was 50 years (range 28-71 years) old. 10/64 (15.6%) were primary mucosal and 21/64 (32.8%) were primary acral, 40 pts were at stage IV and 32% pts got BRAF mutation. At the last follow up of Dec 2018, 5 pts achieved partial response and 27 pts got stable disease. The objective response rate was 10%. The DCR was 64%. The median PFS was 6.0 months (95% CI 1.7-10.3 months). The median overall survival was not reached. The most common adverse events were nausea (56.25%), vomiting (31.25%) and leucopenia (29.7%). Grade 3-4 toxicity was few, one got intermittent palpitation and one got atrial fibrillation, which caused drug discontinuation and recovered to normal. Conclusions: Continuous infusion of endostar plus DTIC and cisplatin improved median PFS as the first line therapy for advanced melanoma. This combination therapy was well tolerated and might be recommended as the first line therapy for advanced melanoma. Clinical trial information: NCT03095079.

scholarly journals NIVOLUMAB EXPERIENCE IN THE TREATMENT OF PRE-TREATED PATIENTS WITH METASTATIC SKIN MELANOMA

2018 ◽  
Vol 8 (3) ◽  
pp. 78-85
Author(s):  
I. V. Samoylenko ◽  
Ya. I. Zhulikov ◽  
G. Yu. Kharkevich ◽  
N. N. Petenko ◽  
L. V. Demidov
Keyword(s):  
Overall Survival ◽  
Metastatic Melanoma ◽  
Median Overall Survival ◽  
Objective Response ◽  
Progression Free Survival ◽  
Subsequent Treatment ◽  
Skin Melanoma ◽  
First Line ◽  
Free Survival ◽  
Line Of Therapy

The appearance of anti-PD-1 drugs significantly improved prognosis of patients with metastatic skin melanoma. However, little data on the effectiveness of these drugs in the second and subsequent lines of therapy has been accumulated in the international literature. We have analyzed our experience in the use of nivolumab in the treatment of metastatic melanoma. This non-randomized, uncontrolled, continuous study included 53 patients with metastatic or unresectable melanoma, of whom 86.8 % (46) received two or more lines of systemic therapy for metastatic melanoma. The rate of objective response was 22.6 % (95 % Confidence Interval (CI) 53.3–64.4 %). The median progression-free survival was 4.37 months (95 % CI 2.27–6.47). The median overall survival was 17.9 months (95 % CI 8.89–26.99). One-, two-, three-year overall survival contained 66, 35 and 35 %, respectively. The efficacy of nivolumab in the second and subsequent treatment lines is significantly lower than showed in the results of randomized trials of the use of anti-PD-1 drugs in the first line of therapy.

Vemurafenib (PLX4032): An Orally Available Inhibitor of Mutated BRAF for the Treatment of Metastatic Melanoma

2011 ◽  
Vol 45 (11) ◽  
pp. 1399-1405 ◽  
Author(s):  
Yasser Heakal ◽  
Mark Kester ◽  
Scott Savage
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Metastatic Melanoma ◽  
Immune Modulation ◽  
English Language ◽  
Objective Response ◽  
Chemotherapeutic Agents ◽  
First Line ◽  
Clinical Safety ◽  
Clinical Trial Registries

Objective: To summarize the preclinical and clinical data on vemurafenib, approved by the Food and Drug Administration (FDA) on August 17, 2011, and discuss the drug's clinical advantages and limitations. Data Sources: An English-language literature search of MEDLINE/PubMed (1966-August 2011), using the terms PLX4032, RG7204, R05185426, vemurafenib, and metastatic melanoma, was conducted. In addition, information and data were obtained from meeting abstracts, clinical trial registries, and news releases from the FDA. Study Selection and Data Extraction: All relevant published articles and abstracts on vemurafenib were included. Clinical trial registries and meeting abstracts were used to obtain information regarding ongoing trials. All peer-reviewed articles containing information regarding the clinical safety and efficacy of vemurafenib were evaluated for inclusion. Data Synthesis: Before the recent approval (March 2011) of ipilimumab, there was no first-line standard-of-care therapy, with proven overall survival benefit, for the treatment of malignant metastatic melanoma. Unlike ipilimumab, which acts through immune-modulation, vemurafenib is a novel, molecularly targeted therapeutic with preferential efficacy toward a specific mutated oncogenic BRAF-signaling mediator. In recently published results of a Phase 3 clinical trial comparing dacarbazine with vemurafenib, vemurafenib prolonged progression-free and overall survival, with confirmed objective response rate of 48% (95% CI 42 to 55) versus 5% (95% CI 3 to 9) for patients who received dacarbazine (p < 0,001) Conclusions: Vemurafenib offers a novel, first-line, personalized therapy for patients who have mutated BRAF, Clinical trials of vemurafenib in combination with ipilimumab or other targeted or cytotoxic chemotherapeutic agents may provide more effective regimens with long-term clinical benefit.

scholarly journals Encorafenib (Braftovi) in Combination With Binimetinib (Mektovi)

2021 ◽  
Vol 1 (7) ◽  
Author(s):  
Reimbursement Team
Keyword(s):  
Metastatic Melanoma ◽  
Gene Mutation ◽  
Combination Treatment ◽  
Braf Inhibitor ◽  
Previous Treatment ◽  
Mek Inhibitor ◽  
Toxicity Profile ◽  
First Line ◽  
Braf V600 Mutation ◽  
Public Drug

CADTH recommends that Braftovi in combination with Mektovi should be reimbursed by public drug plans for the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation if certain conditions are met. Braftovi and Mektovi should only be reimbursed if used in combination and prescribed and monitored by clinicians with expertise in diagnosis and management of melanoma who are familiar with the toxicity profile associated with the Braftovi with Mektovi regimen and if it does not cost more than the least costly BRAF inhibitor and MEK inhibitor (BRAFi/MEKi) combination treatment. Braftovi with Mektovi should only be covered to treat adult patients with advanced or metastatic melanoma who have a BRAF V600 gene mutation that has been identified through a validated test. Patients who have not received previous treatment and patients whose disease has progressed after first-line immunotherapy are eligible for coverage.

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