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Kumar et al. (1987)

Kumar et al. (1987)
Design: Retrospective case series (prognosis), evidence level: 3
Country: India
Inclusion criteria:
Locally advanced fungating breast cancer
Unsuitability for surgery as primary therapy
Presence of distant metastases was acceptable.
Exclusion criteria:
Prior radiotherapy or chemotherapy.
Population:
Number of patients = 30
Interventions:
Patients received 2 cycles of combination chemotherapy before surgery:
Cyclophosphamide at 150 mg on days 1–14
Methotrexate at 10 mg on days 1–5
Prednisone at 30 mg on days 1–14
Fluorouracil at 500 mg iv on days 1–5
14 days rest then cycle repeated.

Following chemotherapy, patients were given simple or modified mastectomy followed by a further 6 cycles of the combined chemotherapy.
Outcomes:
After initial chemotherapy, patients were evaluated for:
Degree of mobiity of the lesion mass
Degree of mobility of nodes
Reduction of ulceration of the mass
Relief of odour, bleeding, well-being, dyspnoea & oedema

Following surgery and further chemotherapy, the outcomes were tumour response: complete response (CR), partial response (PR), no response (NR) or progressive disease (PD) and adverse events.
Follow up:
Baseline appraisal is described as a ‘thorough clinical, haematological, radiological and biochemical evaluation’ with no other details.

Tumour biopsy was performed and samples examined histologically. Results were compared with post-operative specimens.

Follow-up was at monthly intervals but the median term per patient is not stated. The results are reported for 1 yr survival.
Results:
Tumour response after pre-surgical chemotherapy: n (%)
CR = 8 (26.67)
PR (operable) = 10 (33.33)
NR (still operable) = 7 (23.33)
PD (inoperable) = 5 (16.67)

25/30 patients went on to have either a simple mastectomy or mastectomy with axillary clearance.

Following surgery and 6 cycles of post-surgical chemotherapy, after 1 year there were 10 patients with no evidence of disease (33.33%). 4 patients had disease recurrence. 2 patients died from leukopenia and 1 patient was lost to follow-up. It is not clear what happened to the remaining 13 patients.
General comments:
This paper presents data from a (probably) retrospective study which occurred between 1983 and 1984 of patients in India that were treated for fungating breast cancer. No patient characteristics were reported.

This simple, outdated study is of poor quality offering no statistics. Not all patients were accounted for.

From: Chapter 6, Management of specific problems

Cover of Advanced Breast Cancer
Advanced Breast Cancer: Diagnosis and Treatment.
NICE Clinical Guidelines, No. 81.
National Collaborating Centre for Cancer (UK).
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