Combination Chemotherapy with Vinblastine, Bleomycin and Methotrexate in Dtic-resistant Metastatic Melanoma

1979 ◽  
Vol 65 (2) ◽  
pp. 237-240 ◽  
Author(s):  
Gianfranco Porcile ◽  
Mario Musso ◽  
Francesco Boccardo ◽  
Riccardo Rosso ◽  
Leonardo Santi
Keyword(s):  
Malignant Melanoma ◽  
Metastatic Melanoma ◽  
Combination Chemotherapy ◽  
Response Rate ◽  
Objective Response ◽  
Complete Response

Fifteen patients with metastatic DTIC-resistant malignant melanoma were treated with vinblastine, bleomycin and methotrexate combination chemotherapy. Three patients showed an objective response (one complete response). The therapy was well tolerated and easy to administer. This combination appears to produce in DTIC-resistant patients a response rate similar to that obtained with DTIC.

Combination Chemotherapy with 1-Methyl-1-Nitrosourea and Cyclophosphamide in Metastatic Melanoma

1978 ◽  
Vol 64 (1) ◽  
pp. 89-94 ◽  
Author(s):  
Krsto Kolarić ◽  
Anton Roth ◽  
Vera Fuss
Keyword(s):  
Body Weight ◽  
Malignant Melanoma ◽  
Antitumor Activity ◽  
Lymph Nodes ◽  
Metastatic Melanoma ◽  
Combination Chemotherapy ◽  
Tumor Regression ◽  
Objective Response ◽  
Metastatic Malignant Melanoma ◽  
Melanoma Metastasis

Twenty one patients with advanced metastatic melanoma were treated with a combination of 1-methyl-1-nitrosourea (MNU) and cyclophosphamide. AH the patients had not previously been treated with cytostatics. MNU in the dose of 4 mg/kg and cyclophosphamide in the dose of 8 mg/kg body weight was administered daily. The drugs were given in 6 day cycles. Objective response (> 50% tumor regression) was obtained in 8 (38%) of the 21 treated patients, with 2 complete and 6 partial remissions. The duration of remission was 2–12 months (M = 6.2 months). Injections of MNU caused nausea and vomiting in approximately all the treated patients. Combination of these drugs, however, produced myelodepression in 33% of treated patients. This combination of drugs showed antitumor activity in metastatic malignant melanoma, particularly in melanoma metastasis of the lung, brain and lymph nodes and needs further investigation.

Vinblastine, bleomycin, and cis-platinum for the treatment of metastatic malignant melanoma. National Cancer Institute of Canada Melanoma Group.

1984 ◽  
Vol 2 (2) ◽  
pp. 131-134 ◽  
Keyword(s):  
Malignant Melanoma ◽  
Soft Tissue ◽  
Metastatic Melanoma ◽  
Response Rate ◽  
Complete Response ◽  
Metastatic Malignant Melanoma ◽  
Major Toxicity ◽  
Duration Of Response ◽  
Visceral Metastases ◽  
Leukocyte Counts

Sixty-five patients with metastatic melanoma were treated with vinblastine, bleomycin, and cis-diammine dichloroplatinum (VBD). Sixty-four patients were evaluable for response and toxicity. Twelve (19%) of 64 responded. Three patients (5%) achieved a complete response and nine patients (14%) achieved a partial response. Eleven (22%) of 50 previously untreated patients responded. Nine (30%) of 30 women responded while only three (9%) of 34 men responded. All three complete responses were in previously untreated women. Ten (19%) of 52 patients with visceral metastases responded and two (17%) of 12 patients with soft tissue metastases responded. The duration of complete responses was 23, 25, and 32 weeks. The median duration of the partial responses was 20 weeks (range, 12-28 weeks). Major toxicity was encountered. Leukocyte counts less than 1.0 X 10(9)/L were seen in 27% of the patients. There was one sepsis-related death. Platelet counts less than 50 X 10(9)/L were seen in 22% of patients. Mucositis was common. VBD can cause regression of advanced visceral metastatic disease but the low response rate, short duration of response, and major toxicity abrogates most of its utility as initial treatment for metastatic melanoma.

Phase II clinical trial with a second generation, GM-CSF encoding, oncolytic herpesvirus in unresectable metastatic melanoma

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9035-9035 ◽  
Author(s):  
N. N. Senzer ◽  
H. Kaufman ◽  
T. Amatruda ◽  
M. Nemunaitis ◽  
G. Daniels ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Metastatic Melanoma ◽  
Phase Ii ◽  
Response Rate ◽  
Objective Response ◽  
Stage Iv ◽  
Complete Response ◽  
Phase Iii ◽  
Stage Iiic ◽  
Gm Csf

9035 Background: OncoVEXGM-CSF is a an oncolytic HSV, encoding GM-CSF . We recently completed a phase II trial involving 50 advanced melanoma patients (stage IIIc and IV) with at least one injection accessible lesion, including by ultrasound. Methods: Patients received a single IT injection of 106 pfu/ml apportioned between 10 or less injectable tumors, followed 3 wks later by 24 or less sequential injections of 108 pfu/ml every 2 wks until clinically significant disease progression, or overall or injectable lesion complete response. Response (RECIST modified to allow progression before response and biopsy of residual masses) and survival were monitored. Results: All 50 pts have been enrolled and are evaluable (Stage IIIc, n=10; IV M1a, n=16; IV M1b, n=4; IV M1c, n=20). A median of 6 injections were administered. Adverse effects were limited and generally involved transient flu-like symptoms. Both injected and uninjected regional and distant disease demonstrated response including clearly documented responses at uninjected visceral sites. The overall response rate was 26% (8 CR, 5 PR); 10 responses have been maintained for >6 months and 2 are ongoing at <6months, the longest currently being at 35 months from first dose. 93% of patients (14 of 15) with PR, CR or surgical CR remain alive. Ten additional patients had SD for >3 months. Kaplan Meier one year survival is 61% overall, 58% stage IV only, 48% for Stage IV M1c. The median OS is 16+ months. Conclusions: The 1-year survival and durable objective response rate are encouraging. Responses of distant and visceral disease provide further compelling evidence of systemic effectiveness. This, combined with a limited toxicity profile, suggests OncoVEXGM-CSF is a promising treatment for metastatic melanoma. A phase III clinical trial is planned. [Table: see text]

Evaluations of Combination Chemotherapy(DAC-Tam) for Advanced Malignant Melanoma. Possible Patient Groups which may Show a Good Response Rate.

2001 ◽  
Vol 63 (5) ◽  
pp. 561-568
Author(s):  
Hideki KAMIYA ◽  
Hiroyuki KANOH ◽  
Naoki ICHIHASHI ◽  
Yoshiro ICHIKI ◽  
Hajime TAKAGI ◽  
...  
Keyword(s):  
Malignant Melanoma ◽  
Combination Chemotherapy ◽  
Response Rate ◽  
Good Response Rate ◽  
Advanced Malignant Melanoma ◽  
Patient Groups

Phase II Randomized Trial of Temozolomide and Concurrent Radiotherapy in Patients With Brain Metastases

2002 ◽  
Vol 20 (17) ◽  
pp. 3644-3650 ◽  
Author(s):  
D. Antonadou ◽  
M. Paraskevaidis ◽  
G. Sarris ◽  
N. Coliarakis ◽  
I. Economou ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Randomized Trial ◽  
Response Rate ◽  
External Beam Radiotherapy ◽  
Objective Response ◽  
Complete Response ◽  
Hematologic Toxicity ◽  
Neurologic Symptom ◽  
Symptom Evaluation ◽  
Radiotherapy Alone

PURPOSE: To determine the efficacy, tolerability, and safety of concurrent temozolomide and radiotherapy in patients with previously untreated brain metastases. PATIENTS AND METHODS: Fifty-two patients with brain metastases from solid tumors were randomized to oral temozolomide (75 mg/m2/d) concurrent with 40-Gy fractionated conventional external-beam radiotherapy (2 Gy, 5 d/wk) for 4 weeks versus 40-Gy radiotherapy alone. The group receiving temozolomide and radiotherapy continued temozolomide therapy (200 mg/m2/d) for 5 days every 28 days for an additional six cycles. The primary end points were radiologic response and neurologic symptom evaluation. RESULTS: The objective response rate was significantly (P = .017) improved in patients receiving temozolomide and radiotherapy versus radiotherapy alone. Among 24 patients assessable for response in the temozolomide group, 23 (96%) of 24 responded, including nine (38%) patients with a complete response and 14 (58%) patients with a partial response. With radiotherapy alone, 14 (67%) of 21 assessable patients responded, including seven (33%) complete responses and seven (33%) partial responses. There was marked neurologic improvement in the group receiving temozolomide, and the proportion of patients requiring corticosteroids 2 months after treatment was lower in the temozolomide group compared with radiotherapy alone (67% v 91%, respectively). Daily temozolomide concurrent with radiotherapy was generally well tolerated; however, grade ≥ 2 nausea (48% v 13%, P = .13) and vomiting (32% v 0%, P = .004) were significantly increased in the temozolomide group. Hematologic toxicity was predictable and reversible. CONCLUSION: Temozolomide is safe, and a significant improvement in response rate was observed when administered in combination with radiotherapy in patients with previously untreated brain metastases. A larger randomized trial is warranted to verify these results.

scholarly journals Pooled analysis of 115 patients from updated data of Epitopes-HPV01 and Epitopes-HPV02 studies in first-line advanced anal squamous cell carcinoma

2020 ◽  
Vol 12 ◽  
pp. 175883592097535 ◽  
Author(s):  
Stefano Kim ◽  
Aurélia Meurisse ◽  
Laurie Spehner ◽  
Morgane Stouvenot ◽  
Eric François ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Response Rate ◽  
Objective Response ◽  
Locally Advanced ◽  
Complete Response ◽  
Pooled Analysis ◽  
Term Survival ◽  
Anal Squamous Cell Carcinoma

Aims: The addition of docetaxel to cisplatin and 5-fluorouracil (DCF) has shown promising efficacy in advanced squamous cell carcinoma of the anus (SCCA). Preliminary results of Epitopes-HPV01 study showed a high rate of long-lasting complete response to DCF. The prospective, multicenter, Epitopes-HPV02 trial then confirmed the high efficacy of the modified DCF (mDCF) regimen in terms of complete response rate and long-term survival in metastatic or non-resectable locally advanced recurrent SCCA. Here, we present updated results of the Epitopes-HPV01 and Epitopes-HPV02 studies. Patients & methods: Epitopes-HPV01 is a prospective study performed by the regional cancer network of Franche-Comté, France. Epitopes-HPV02 is a phase II study supported by two French collaborative oncological groups, performed in 25 centers. Both studies included patients with metastatic, or with unresectable local recurrent SCCA, treated with DCF regimen. Results: In Epitopes-HPV01, 51 patients were enrolled between September 2012 and January 2019, and 49 patients were included for analysis; while 69 patients were included between September 2014 and December 2016 in Epitopes-HPV02, and 66 patients for analysis. Pooled analysis of 115 patients showed a median progression-free survival of 12.2 months [95% confidence interval (CI) 10.6–16.1] [11.0 months (9.3–16.0) in -HPV02, and 15.6 months (11.2–34.5) in -HPV01, ( p = 0.06)]. The median overall survival was 39.2 months (26.0–109.1) [36.3 in -HPV02 (25.2–NR), and 61.1 months (21.4–120.0) in -HPV01 ( p = 0.62)]. Objective response rate was 87.7% (90.9% in -HPV02 and 83.3% in -HPV01) with 40.3% of complete response (45.5% in -HPV02 and 33.3% in -HPV01). No differences were observed between standard DCF ( n = 54) and mDCF ( n = 58) in terms of OS ( p = 0.57) and PFS ( p = 0.99). 5-years PFS and OS rates were 24.5% and 44.4%, respectively, in the whole population. No treatment-related death was observed. Conclusion: Updated results of Epitopes-HPV01 and 02 studies, as well as the pooled analysis, confirm mDCF as a standard treatment in patients with advanced SCCA.

Phase II Results of Bendamustine in Combination with Rituximab in Relapsed Indolent and Mantle-Cell Non-Hodgkin’s Lymphoma.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2710-2710 ◽  
Author(s):  
Richard H. Van der Jagt ◽  
Philip Cohen ◽  
Bruce D. Cheson ◽  
Anil Tulpule ◽  
Jordan A. Herst ◽  
...  
Keyword(s):  
Phase Ii ◽  
Objective Response Rate ◽  
Response Rate ◽  
Objective Response ◽  
Complete Response ◽  
Hodgkin's Lymphoma ◽  
Prior Chemotherapy ◽  
Non Hodgkin's Lymphoma ◽  
Mantle Cell ◽  
Grade 3

Abstract Objective: The objective of this study was to evaluate the efficacy and safety of bendamustine HCl (TREANDA®) in combination with rituximab in patients with relapsed non-Hodgkin’s lymphoma (NHL). Background: Bendamustine is a novel hybrid, alkylating agent with single-agent activity in multiple hematologic and solid tumors. It induces cell death via both apoptosis and the apoptosis-independent pathway of mitotic catastrophe. The combination of bendamustine and rituximab has been shown to exhibit a synergistic antitumor effect on NHL cells. Methods: This Phase II, multicenter study enrolled adult patients with relapsed, indolent B-cell or mantle-cell NHL who were not refractory to rituximab (defined as progression ≤6 months of last rituximab dose). Patients received rituximab 375 mg/m2 intravenously (IV) on day 1 and bendamustine 90 mg/m2 IV on days 2 and 3 of a 28-day cycle for 4 to 6 cycles. An additional dose of rituximab 375 mg/m2 IV was given 1 week before the first cycle of bendamustine and 4 weeks after the last cycle. Results: The intent-to-treat (ITT) population included 66 patients (59% men) with a median age of 60 years (range, 40–84). Indolent histologic phenotype was seen in 54 patients with the following histologic subtypes: follicular center cell (61%), small lymphocytic (15%), lymphoplasmacytic (3%), and marginal zone (3%); 18% had mantle-cell lymphoma (MCL). A total of 85% of patients had stage III/IV disease. These patients relapsed from a median of 1 prior chemotherapy (range: 0–5), with 56% having had prior treatment with rituximab. Patients with no prior chemotherapy relapsed following biologic therapy. In the ITT population, the overall objective response rate (ORR) was 94% (complete response [CR]/complete response unconfirmed [CRu], 41%; partial response [PR], 53%); 6% had stable disease. The ORR for the 12 MCL patients was 92% (CR/CRu, 42%; PR 50%). For all patients, the median duration of response and progression-free survival has not been reached after a median follow-up of 8.3 months (range, 0.14–31 months). Grade 3/4 neutropenia was seen in 41% of patients (7%, febrile neutropenia). Common nonhematologic toxicities (grade 1/2, grade 3, grade 4) were nausea (68%, 0%, 0%) and fatigue (53%, 5%, 0%); one patient had grade 3 sepsis. No alopecia was observed. Conclusions: Bendamustine administered in combination with rituximab produced a high objective response rate and was generally well tolerated in patients with relapsed indolent and mantle-cell NHL who were not refractory to rituximab. These results suggest that the combination of bendamustine and rituximab may be comparable in activity to R-CHOP, and further studies of this combination are warranted.

Multi-institutional phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients (pts) with advanced non-small cell lung cancer (NSCLC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18179-18179
Author(s):  
J. Sasaki ◽  
H. Uramoto ◽  
K. Kashiwabara ◽  
H. Kishi ◽  
E. Moriyam ◽  
...  
Keyword(s):  
Phase Ii ◽  
Combination Chemotherapy ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Group Performance ◽  
Phase Ii Study ◽  
Single Agent ◽  
Objective Response ◽  
Efficacy And Safety ◽  
Grade 3

18179 Background: Because elderly pts may tolerate platinum-based combination chemotherapy poorly, single-agent chemotherapy is selected for the treatment regimen. However, retrospective subgroup analyses have consistently indicated that elderly pts indeed benefit from platinum-based combination chemotherapy as well as their younger counterparts. This phase II study evaluated the efficacy and safety of carboplatin-gemcitabine combination chemotherapy in elderly pts with advanced NSCLC. Methods: Fifty-four pts aged more than 70 years old (median, 77; range, 70–88) with previously untreated advanced NSCLC were enrolled on this trial. Additional criteria included the presence of measurable lesions, an Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate organ function. Pts received carboplatin at an area under the curve of 4 mg/ml/min on the first day and gemcitabine at 1000 mg/m2 on the first and eighth day of consecutive 3 week periods. The primary endpoint was to determine the objective response rate of this platinum-doublet regimen. The RECIST criteria were used to measure response. Results: Enrolled pts included 15/39 with stage IIIB/IV diseases. Fifty-one out of enrolled pts were eligible for efficacy and safety analyses. The median number of treatment cycles was 4 (range, 1–7). Fifteen partial responses (response rate: 29%) were obtained. The median TTP was 118 days. Hematological toxicities of grade 3/4 included leukopenia (46%), neutropenia (72%) and thrombocytopenia (50%). Non-hematological toxicities of grade 3/4 included nausea (6%), appetite loss (7%), fatigue (7%) and infection (9%). Conclusions: The combination carboplatin-gemcitabine at these doses has shown activity with a favorable toxicity profile for fit elderly pts with advanced NSCLC. No significant financial relationships to disclose.

Phase II study of combination chemotherapy with biweekly cetuximab and irinotecan for wild-type KRAS metastatic colorectal cancer refractory to irinotecan, oxaliplatin, and fluoropyrimidines.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 561-561
Author(s):  
S. Yuki ◽  
K. Shitara ◽  
M. Yoshida ◽  
D. Takahari ◽  
S. Utsunomiya ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Combination Chemotherapy ◽  
Response Rate ◽  
Standard Dose ◽  
Objective Response ◽  
Progression Free Survival ◽  
Wild Type ◽  
Standard Regimen ◽  
Free Survival

561 Background: Weekly cetuximab and irinotecan is a standard regimen in heavily pretreated patients with metastatic colorectal cancer (MCRC). The aim of this study was to prospectively evaluate the efficacy of combination chemotherapy with biweekly cetuximab and irinotecan in patients with pretreated MCRC harboring wild-type KRAS. Methods: Patients with wild- type KRAS MCRC that had progressed after chemotherapy with irinotecan, oxaliplatin, and fluoropyrimidine were included in this study. Cetuximab was administered at 500 mg/m2 biweekly with irinotecan. The primary endpoint was response rate. The secondary endpoints included adverse events, progression-free survival, and overall survival. The pharmacokinetics of cetuximab was also evaluated in five patients. Results: From May, 2009 to February, 2010, a total of 31 patients were enrolled from five institutions. One patient was not eligible. Among the 30 assessable patients, ECOG PS was 0 in 12, 1 in 16, and 2 in two patients. The objective response rate was 30.0% (95% confidence interval [CI], 14.7-49.4), and the disease control rate (complete response, partial response, or stable disease) was 76.7% (95%CI, 61.4-92.3). The median progression-free survival was 5.3 months (95%CI, 3.4-7.3). Grade 3 skin toxicity was observed in 3 patients (10%), and treatment related death due to pneumonia occurred in one patient. Conclusions: The efficacy data are similar to those of standard dose of cetuximab plus irinotecan. Combination chemotherapy with biweekly cetuximab and irinotecan is effective for pretreated metastatic wild-type KRAS MCRC. No significant financial relationships to disclose.

Triplet chemotherapy (TC) with FOLFIRINOX regimen in metastatic colorectal cancer (mCRC): Experience of the Val d’Aurelle Center.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 3633-3633
Author(s):  
Emmanuelle Samalin ◽  
Virginie Loriot ◽  
Simon Thézenas ◽  
Eric Assenat ◽  
Fabienne Portales ◽  
...  
Keyword(s):  
Overall Survival ◽  
Liver Metastases ◽  
Targeted Therapies ◽  
Primary Tumor ◽  
Response Rate ◽  
Objective Response ◽  
Complete Response ◽  
Median Number ◽  
Grade 3 ◽  
The Impact

3633 Background: TC is a treatment option for mCRC to improve the tumor response rate in selected patients (pts) and the conversion rate of initially non-resectable liver metastases. The aim of this study was to evaluate the impact and feasibility of FOLFIRINOX regimen in mCRC pts. Methods: All mCRC pts with non-resectable disease who have received FOLFIRINOX alone or combined with targeted therapies (bevacizumab or cetuximab) from October 2000 to December 2010 were selected for this analysis. Clinical data were collected in a mCRC specific data base and analyzed by the end of 2011. Results: Ninety two pts (52% of men), median age 59 yrs (range: 27-76) were treated with FOLFIRINOX (D1 oxaliplatin 85 mg/m² IV 2H then irinotecan 180 mg/m² IV 90 min and elvorin 200 mg/m², then 5FU 200 mg/m² and 2400 mg/m² by 46H infusion, D1=D15) alone (64%) or combined with cetuximab(30%) or bevacizumab (6%), as 1st-line in 82 pts (89%). Prophyllactic G-CSF was given in 58% of them. Primary tumor was located in colon (58%) or rectum (42%), and 64 (69%) of pts presented with synchronous metastases: liver 100%, lung 40%, peritoneum 17% and nodes 17%. Median number of cures was 8 (range: 1-12). There was 1 toxic death. Grade 3-4 toxicities were: diarrhea 22%, neuropathy 21%, cutaneous 12%, neutropenia 28%, febrile neutropenia 0%, thrombopenia 6%. Objective Response rate according to RECIST criteria was 72% [CI95% 61-81] including 10 pts with complete response (11%). The primary tumor was resected in 70 pts (76%) and 14% had KRAS mutated tumor. Among the pts with liver metastases, 63 (68%) pts were evaluated for secondary resectability by a multidisciplinary committee and 40 pts (43%) had resection achieved (70% R0). Median overall survival was 49 months [CI95%28-62]. Conclusions: These results confirm the feasibility of FOLFIRINOX regimen with or without targeted therapies and its efficacy in terms of response rate and overall survival as 1rst-line treatment in selected mCRC pts.

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