Intravenous Administration of BCG in Advanced Melanoma Patients

1978 ◽  
Vol 64 (4) ◽  
pp. 437-443 ◽  
Author(s):  
Sergio Orefice ◽  
Natale Cascinelli ◽  
Maurizio Vaglini ◽  
Umberto Veronesi

From June 1975 to August 1977, 19 patients with distant metastases of malignant melanoma of the skin that were no longer responsive to chemotherapy were treated with BCG given intravenously. A single dose of lyophilized Pasteur BCG ranging from 2×107 to to 3×108 viable units was given in 500 ml of saline infused in 5 to 6 h. Seven of the 16 evaluable patients benefited from treatment; 3 showed an objective regression of more than 50% of the original tumor volume, and 4 an arrest of tumor growth. The objective regressions lasted from 2 to 5 months, and 1 case had an arrest of tumor growth for 29 months. The regression rate was related to the BCG dosage: 2×108 viable units appears to be the dosage that gives severe but reversible toxicity and is able to induce objective regression. The most responsive lesions were skin and subcutaneous deposits (5 of 7) and lung metastases (1 of 4). Toxic effects seem to be related to the number of bacilli injected. In the group of 10 cases treated with less than 108 units, toxicity was modest: 4 patients had fever (up to 38.5 °C) that lasted a few days, and in 3 cases it was associated with shivering during the infusion period and weakness. One case only had vomiting and jaundice. Toxicity was severe in the 9 patients that were treated with a dosage higher than 108: patients had fever and weakness for at least 4 days and shivering during the infusion. Two had adrenal insufficiency and 7 had liver enlargement and jaundice with return to normality by day 21. In the whole series 8 patients had leucopenia and 5 thrombocytopenia for 2 to 3 days: only 1 patient required blood and platelet transfusion. No significant variations in immunoglobulin levels were observed. No variations of PPD or BCG skin tests were observed after treatment. Three patients expired; the first, treated with 6×107 units, had an intercurrent disease (autopsy showed a heart infarction); the second, treated with 1.8×108, showed a rapid growth of lung metastases and died 15 days after treatment; the death of the third patient was probably due to anaphylactic shock. All 3 patients had been previously treated with BCG, given by scarification or intranodular injection.

2021 ◽  
Vol 9 (2) ◽  
pp. e001701
Author(s):  
Julia Maria Ressler ◽  
Matthias Karasek ◽  
Lukas Koch ◽  
Rita Silmbrod ◽  
Joanna Mangana ◽  
...  

BackgroundTalimogene laherparepvec (T-VEC) is a licensed therapy for use in melanoma patients of stage IIIB-IVM1a with injectable, unresectable metastatic lesions in Europe. Approval was based on the Oncovex Pivotal Trial in Melanoma study, which also included patients with distant metastases and demonstrated an overall response rate (ORR) of 40.5% and a complete response (CR) rate of 16.6%.ObjectivesThe aim of this study was to assess the outcome of melanoma patients treated with T-VEC in a real-life clinical setting.MethodsBased on data from 10 melanoma centers in Austria, Switzerland and southern Germany, we conducted a retrospective chart review, which included 88 patients (44 male, 44 female) with a median age of 72 years (range 36–95 years) treated with T-VEC during the period from May 2016 to January 2020.Results88 patients fulfilled the inclusion criteria for analysis. The ORR was 63.7%. 38 patients (43.2%) showed a CR, 18 (20.5%) had a partial response, 8 (9.1%) had stable disease and 24 (27.3%) patients had a progressive disease. The median treatment period was 19 weeks (range: 1–65), an average of 11 doses (range: 1–36) were applied. 39 (45.3%) patients developed adverse events, mostly mild, grade I (64.1%).ConclusionThis real-life cohort treatment with T-VEC showed a high ORR and a large number of durable CRs.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Tianwen Luo ◽  
Yutong Wang ◽  
Xuefeng Shan ◽  
Ye Bai ◽  
Chun Huang ◽  
...  

Abstract Background The identification of the homogeneous and heterogeneous risk factors for different types of metastases in colorectal cancer (CRC) may shed light on the aetiology and help individualize prophylactic treatment. The present study characterized the incidence differences and identified the homogeneous and heterogeneous risk factors associated with distant metastases in CRC. Methods CRC patients registered in the SEER database between 2010 and 2016 were included in this study. Logistic regression was used to analyse homogeneous and heterogeneous risk factors for the occurrence of different types of metastases. Nomograms were constructed to predict the risk for developing metastases, and the performance was quantitatively assessed using the receiver operating characteristics (ROC) curve and calibration curve. Results A total of 204,595 eligible CRC patients were included in our study, and 17.07% of them had distant metastases. The overall incidences of liver metastases, lung metastases, bone metastases, and brain metastases were 15.34%, 5.22%, 1.26%, and 0.29%, respectively. The incidence of distant metastases differed by age, gender, and the original CRC sites. Poorly differentiated grade, more lymphatic metastasis, higher carcinoembryonic antigen (CEA), and different metastatic organs were all positively associated with four patterns of metastases. In contrast, age, sex, race, insurance status, position, and T stage were heterogeneously associated with metastases. The calibration and ROC curves exhibited good performance for predicting distant metastases. Conclusions The incidence of distant metastases in CRC exhibited distinct differences, and the patients had homogeneous and heterogeneous associated risk factors. Although limited risk factors were included in the present study, the established nomogram showed good prediction performance.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9576-9576
Author(s):  
Kevin Lynch ◽  
Yinin Hu ◽  
Norma Farrow ◽  
Yun Song ◽  
Max Meneveau ◽  
...  

9576 Background: While management of the nodal basin for melanoma has largely moved to observation for microscopic sentinel lymph node (SLN) metastasis, complete lymph node dissection (CLND) remains the current standard of care for melanoma patients with macroscopic, clinically detectable lymph node metastases (cLN). As CLND is associated with high surgical morbidity, we sought to study whether cLN may be safely managed by excision of only clinically abnormal nodes (precision lymph node dissection, PLND). Currently, a small subset of patients with cLN do not undergo CLND because of frailty or patient preference. We hypothesized that in these selected patients, PLND would provide acceptable regional control rates. Methods: Retrospective chart review was conducted at four academic tertiary care hospitals to identify melanoma patients who underwent PLND for cLN. cLN were defined as palpable or radiographically abnormal nodes. Recurrences were categorized as local/in-transit, same-basin lymph node, or distal lymph node/visceral. The primary outcome was isolated same-basin recurrence after PLND. Results: Twenty-one patients underwent PLND for cLN without synchronous distant metastases (characteristics of primary lesions summarized in Table). Reasons for forgoing CLND included patient preference (n=8), imaging indeterminate for distant metastases (n=2), comorbidities (n=4), loss to follow up (n=1), partial response to checkpoint blockade (n=1), or not reported (n=5). The inguinal node basin was the most common site (n=10), followed by the axillary (n=8) and cervical basins (n=3). A median of 2 nodes were resected at PLND, and 68% of resected nodes were positive for melanoma (median: 1, range: 1-3 nodes). Median follow-up was 23 months from PLND, and recurrence was observed in 28.6% of patients overall. Only 1 patient (4.8%) developed an isolated same-basin recurrence. The 3-year cumulative incidence of isolated same-basin recurrence was 5.3%, while risk of isolated local/in-transit recurrence or distant basin/visceral metastasis were 19.8% and 33.3%, respectively. Complications from PLND were reported in 1 patient (4.8%) and were limited to post-operative seroma and lymphedema. Conclusions: These pilot data suggest that PLND may offer acceptable regional disease control for cLN. Post-operative morbidity from PLND was also low, raising the possibility that PLND may provide adequate regional disease control without the morbidity associated with CLND. These data justify additional, prospective evaluation of PLND in selected patients.[Table: see text]


1989 ◽  
Vol 75 (6) ◽  
pp. 597-599 ◽  
Author(s):  
Marco Benasso ◽  
Alejandro Ferro ◽  
Almalina Bacigalupo ◽  
Salvatore Toma ◽  
Silvio Vitriolo ◽  
...  

The present paper reports a retrospective analysis of 16 patients with distant metastases from squamous cell carcinoma of the head and neck observed in our Institute in the last 10 years. Nine patients out of 16 underwent chemotherapy (7 patients), chemotherapy and radiotherapy (1 patient), or an alternating chemo-radiotherapy regimen (1 patient). The remaining 7 patients were not considered for a palliative treatment because of a poor performance status. Two complete responses, 2 partial responses, 2 stable diseases and 3 progressions were observed, with an overall response rate of 44 %. Chemotherapy, when administrable, showed a temporary effectiveness, at least in patients with lung metastases. The combination of cisplatin and 5-fluorouracil seems to maintain the efficacy already shown in patients with locally relapsed disease.


2015 ◽  
Vol 3 (Suppl 2) ◽  
pp. P126 ◽  
Author(s):  
Prashanth Prithviraj ◽  
Grant McArthur ◽  
Victoria Atkinson ◽  
Phillip Parente ◽  
Miles Andrews ◽  
...  

Sarcoma ◽  
2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Hanna M. Fuglø ◽  
Katja Maretty-Nielsen ◽  
Dorrit Hovgaard ◽  
Johnny Ø. Keller ◽  
Akmal A. Safwat ◽  
...  

Purpose. To assess the metastatic pattern of the histological subtype myxoid liposarcoma (MLS) with no or few round cells.Methods. Forty-five patients (F/M = 27/18, mean age 49 (range 17–85) years) were diagnosed with MLS at two Danish sarcoma centres in the period 1995–2004. A retrospective review of patients' files combined with an extraction of survival data from the Danish Centralised Civil Register was performed.Results. Seven patients had distant metastases during the observation period. Two patients had metastases at the time of diagnosis, while metastases occurred within 2.5 years in four patients, and in one patient 11.9 years after primary diagnosis. All metastases occurred at extrapulmonary sites. The first local relapse occurred within 3 years after surgery in six patients, in one patient after 4.0 years, and in one patient 7.7 years after surgery. The 5- and 10-year overall survival was 80% and 69%, respectively. Both the 5- and 10-year distant metastases-free survival was, respectively, 86%. The 5- and 10-year local relapse-free survival was, respectively, 83% and 80%.Conclusions. Patients with MLS had only extra-pulmonary metastases, and no lung metastases were found. Most local relapses and distant metastases occurred within the first 2-3 years after surgery.


1998 ◽  
Vol 16 (9) ◽  
pp. 2913-2920 ◽  
Author(s):  
E C Hsueh ◽  
R K Gupta ◽  
K Qi ◽  
D L Morton

PURPOSE The mechanisms that underlie the clinical efficacy of melanoma vaccines are not well understood. We hypothesized that the type and strength of the immune response generated by CancerVax (John Wayne Cancer Institute, Santa Monica, CA), a polyvalent melanoma cell vaccine (PMCV), might be correlated with its effect on overall survival (OS). PATIENTS AND METHODS Seventy-seven patients began PMCV therapy after complete surgical resection of distant metastatic melanoma. During the first two treatments, PMCV was administered with bacille Calmette-Guerin (BCG). Blood was drawn at 0, 2, 4, 8, and 12 weeks to measure serum titers of immunoglobulin G (IgG) and IgM antibodies against a tumor-associated 90-kd glycoprotein antigen (TA90) expressed on most melanoma cells, including those of PMCV. Cellular immune response to PMCV was assessed by delayed-type hypersensitivity (DTH). General immune competence was assessed by skin tests to purified protein derivative (PPD), mumps, and candida. RESULTS Median follow-up time was 31.5 months. Within the first 12 weeks of PMCV immunotherapy, there was a significant increase in the anti-TA90 IgM (P=.0001) and IgG titers (P=.0001), and in the DTH response to PMCV (P=.0001). Univariate analysis showed that high anti-TA90 IgM titer and strong PMCV-DTH were associated with improved survival (P=.051 and .0173, respectively), whereas elevated anti-TA90 IgG was correlated with decreased survival (P=.0119). Multivariate analysis considering clinical variables and PMCV immune responses identified anti-TA90 IgM, anti-TA90 IgG, and PMCV-DTH as significant independent variables influencing survival following PMCV immunotherapy (P=.0342, .0105, and .0082, respectively). These responses to PMCV were not correlated with immune responses to BCG and therefore were not a manifestation of general immune competence for responses to unrelated antigens. The median survival time and 5-year survival rate were more than 76 months and 75%, respectively, if both anti-TA90 IgM and PMCV-DTH responses were strong (> or = 800 and > or = 7 mm, respectively; n=29); 32 months and 36%, respectively, if only one response was strong (n=35); and 19 months and 8%, respectively, if neither was strong (n=13) (P < .0001). CONCLUSION PMCV induces both humoral and cell-mediated immune responses to melanoma-associated tumor antigens, the type and strength of which appear to be directly related to its therapeutic efficacy.


2000 ◽  
Vol 86 (4) ◽  
pp. 349-350 ◽  
Author(s):  
Claudio Pizzocaro ◽  
Pier Luigi Rossini ◽  
Gian Carlo Magri ◽  
Giorgio Manca ◽  
Claudio Caglioni ◽  
...  

The accuracy of the sentinel node (SN) technique in the evaluation of lymph node involvement in melanoma was evaluated in 71 consecutive patients with localized disease and Breslow index >1 mm. Lymphoscintigraphy identified at least one SN in 70 of the 71 patients (98.5%). The following day 69 patients underwent selective SN excision. The SN was identified by portable probe. One hundred and twenty-two lymph nodes were removed, 14 (11.4%) of which were metastatic in 9 patients (13%). No metastases were found in 40 patients with Breslow <2 mm. Eight of the 9 patients with positive SNs underwent lymphadenectomy of the whole basin and in two patients new metastatic nodes were found. At 4–26 months’ follow-up 1 of the 60 patients with negative SN (scalp melanoma with Breslow 6.2 mm) developed bilateral cervical metastatic nodes. Two more patients with Breslow 3.7 and 5 mm, respectively, developed liver and lung metastases. The remaining 57 patients are still disease free. Among the 9 patients with tumor-positive SNs, 1 was lost to follow-up, 3 died and 5 are still alive. Our data confirm the clinical reliability of the SN technique in melanoma; we feel the technnique should be considered a standard tool in the evaluation of melanoma patients.


2017 ◽  
Vol 10 (3) ◽  
pp. 928-937 ◽  
Author(s):  
Chio Okuyama ◽  
Mitsuhiro Kimura ◽  
Minori Oda ◽  
Naohiro Kodani ◽  
Norihiro Aibe ◽  
...  

Differentiated thyroid carcinoma is an uncommon malignancy of childhood and adolescence that is unique because it has an overall favorable prognosis despite its relatively high rate of nodal and distant metastases. Total thyroidectomy and positive 131I therapy are recommended for cases with pulmonary metastases. In contrast, anaplastic thyroid cancer is one of the most aggressive malignancies that have an unfavorable and miserable prognosis. We report a case with an impressively long history. The patient had multiple pulmonary metastases that had been diagnosed by 131I administration when he was 14 years old, about 45 years before he underwent thyroidectomy. He had been kept unaware of his disease by his family and received no treatment for most of his life. Pulmonary nodules were noted at several medical checkups and showed a remarkable decrease in size during the untreated 44-year period after the 131I administration. At age 58, his thyroid cancer was first detected and total thyroidectomy was performed, with subsequent radioiodine therapy for pulmonary metastases. Unfortunately, anaplastic carcinoma developed and he died of disseminated tumors later.


Sign in / Sign up

Export Citation Format

Share Document