Randomized study of Corynebacterium parvum adjuvant therapy following surgery for (stage II) malignant melanoma.

2.50
Hdl Handle:
http://hdl.handle.net/10541/108008
Title:
Randomized study of Corynebacterium parvum adjuvant therapy following surgery for (stage II) malignant melanoma.
Authors:
Thatcher, Nick; Mene, A R; Banerjee, Saumitra S; Craig, P; Gleave, N; Orton, C
Abstract:
One hundred and fifteen patients with histologically proven primary cutaneous melanoma were entered into a randomized prospective study following surgical removal of clinically obvious regional metastases. The study started in 1977 and was completed in June 1982. Fifty-eight patients (10 with regional skin metastases and 48 with regional node metastases) were in the control group and 57 (15 regional skin, and 42 regional node metastases) received adjuvant C. parvum. Other clinical features were well balanced for each group. C. parvum, 2 mg/m2 IV was repeated eight times at three weekly intervals. The schedule was based on previous work which indicated significant increase in killer cell activity. There was no serious toxicity and 22 patients exhibited tachyphylaxis. Seventeen patients in the control group (11 tumour free) are alive at 24-80 months, and 20 patients in the C. parvum group (12 tumour free) are alive 24-76 months from randomization. No statistically significant difference (P greater than 0.05) was observed between the two patient groups for overall survival (median 26 months) or relapse free survival (median 8 months) from the date of randomization. Nor was the overall survival from the date of primary surgery (median 52 months, range 4-237) or the relapse free survival, median 28 months, range 2-225, significantly different between the two groups of patients. The relapse pattern in the two groups, and survival after relapse were no different though the response rate to actinomycin D and DTIC chemotherapy was significantly higher in the control (48 per cent) than in the C. parvum (23 per cent) group. Toxicity to chemotherapy was not significantly affected by previous C. parvum treatment. Although there were trends for better survival, in the C. parvum patient group, statistically significant activity has not been noted in this study.
Affiliation:
Cancer Research Campaign, Department of Medical Oncology, Christie Hospital and Holt Radium Institute, Manchester.
Citation:
Randomized study of Corynebacterium parvum adjuvant therapy following surgery for (stage II) malignant melanoma. 1986, 73 (2):111-5 Br J Surg
Journal:
The British Journal of Surgery
Issue Date:
Feb-1986
URI:
http://hdl.handle.net/10541/108008
DOI:
10.1002/bjs.1800730211
PubMed ID:
3512025
Type:
Article
Language:
en
ISSN:
0007-1323
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorThatcher, Nicken
dc.contributor.authorMene, A Ren
dc.contributor.authorBanerjee, Saumitra Sen
dc.contributor.authorCraig, Pen
dc.contributor.authorGleave, Nen
dc.contributor.authorOrton, Cen
dc.date.accessioned2010-07-21T10:20:24Z-
dc.date.available2010-07-21T10:20:24Z-
dc.date.issued1986-02-
dc.identifier.citationRandomized study of Corynebacterium parvum adjuvant therapy following surgery for (stage II) malignant melanoma. 1986, 73 (2):111-5 Br J Surgen
dc.identifier.issn0007-1323-
dc.identifier.pmid3512025-
dc.identifier.doi10.1002/bjs.1800730211-
dc.identifier.urihttp://hdl.handle.net/10541/108008-
dc.description.abstractOne hundred and fifteen patients with histologically proven primary cutaneous melanoma were entered into a randomized prospective study following surgical removal of clinically obvious regional metastases. The study started in 1977 and was completed in June 1982. Fifty-eight patients (10 with regional skin metastases and 48 with regional node metastases) were in the control group and 57 (15 regional skin, and 42 regional node metastases) received adjuvant C. parvum. Other clinical features were well balanced for each group. C. parvum, 2 mg/m2 IV was repeated eight times at three weekly intervals. The schedule was based on previous work which indicated significant increase in killer cell activity. There was no serious toxicity and 22 patients exhibited tachyphylaxis. Seventeen patients in the control group (11 tumour free) are alive at 24-80 months, and 20 patients in the C. parvum group (12 tumour free) are alive 24-76 months from randomization. No statistically significant difference (P greater than 0.05) was observed between the two patient groups for overall survival (median 26 months) or relapse free survival (median 8 months) from the date of randomization. Nor was the overall survival from the date of primary surgery (median 52 months, range 4-237) or the relapse free survival, median 28 months, range 2-225, significantly different between the two groups of patients. The relapse pattern in the two groups, and survival after relapse were no different though the response rate to actinomycin D and DTIC chemotherapy was significantly higher in the control (48 per cent) than in the C. parvum (23 per cent) group. Toxicity to chemotherapy was not significantly affected by previous C. parvum treatment. Although there were trends for better survival, in the C. parvum patient group, statistically significant activity has not been noted in this study.en
dc.language.isoenen
dc.subjectSkin Canceren
dc.subject.meshAdjuvants, Immunologic-
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshClinical Trials as Topic-
dc.subject.meshCombined Modality Therapy-
dc.subject.meshDacarbazine-
dc.subject.meshDactinomycin-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshMale-
dc.subject.meshMelanoma-
dc.subject.meshMiddle Aged-
dc.subject.meshPostoperative Period-
dc.subject.meshPropionibacterium acnes-
dc.subject.meshProspective Studies-
dc.subject.meshRandom Allocation-
dc.subject.meshSkin Neoplasms-
dc.titleRandomized study of Corynebacterium parvum adjuvant therapy following surgery for (stage II) malignant melanoma.en
dc.typeArticleen
dc.contributor.departmentCancer Research Campaign, Department of Medical Oncology, Christie Hospital and Holt Radium Institute, Manchester.en
dc.identifier.journalThe British Journal of Surgeryen

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