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Biomedical subjects

P Donnellan

Publications and source records attributed to P Donnellan.

6 recordsLinked to original sources

A randomized phase II trial of SRL172 (Mycobacterium vaccae) +/- low-dose interleukin-2 in the treatment of metastatic malignant melanoma.

We conducted a randomized phase II trial of SRL172 (Mycobacterium vaccae) +/- low-dose interleukin-2 (IL-2) as treatment for stage IV malignant melanoma. The objectives were to establish the safety and efficacy of SRL172 with and without IL-2. All patients had measurable metastatic disease and none received concurrent chemotherapy, radiotherapy, corticosteroids or any other investigational agent. Sixteen patients were randomized into each arm of the trial prior to closure. The trial was halted prematurely when no responses were seen in the first 16 patients receiving SRL172 alone, predicting a response rate of less than 20%. Three partial remissions were seen in the 16 patients receiving SRL172 + IL-2. These patients remained on monthly SRL172 + IL-2, with disease progression at 12, 15 and 23 months. They continued on the trial regimen following surgical management of their disease progression. This trial provides preliminary evidence of a new, non-toxic, immunotherapeutic regimen in the management of malignant melanoma. Further trials are required to establish a definitive response rate and to compare the combination regimen with the regimen of low-dose IL-2 used in this trial. A biological basis for the responses seen in the SRL172 + IL-2 arm also needs to be established.

Adjuvants, Immunologic↗

Odynorgasmia.

Painful ejaculation ("odynorgasmia") is not well recognized. When it occurs it may indicate the precise site of pathology.

Ejaculation↗

Informed consent and randomised controlled trials.

Truly informed consent is a difficult thing to achieve! Patients are not healthy volunteers and their vulnerability challenges their ability to assess the risk/benefit of health choices. In this paper we consider some or the issues surrounding this important aspect of modern practice, and offer some suggestions on how to improve the process, with the goal of increasing participation in clinical research, and enhancing patients' confidence in their medical advisors.

Ethics, Medical↗

Cytomegalovirus pneumonia in a patient with breast cancer on chemotherapy: case report and review of the literature.

Cytomegalovirus (CMV) pneumonia in the setting of non-transplantation patients is a rarity. We present a case of CMV pneumonitis in a woman with stage IV breast cancer, with brain metastases, receiving both chemotherapy and systemic corticosteroids. A review of the literature reveals this as a unique case. Potential viral etiologies should therefore be considered in cancer patients with pneumonia receiving non-transplantation chemotherapy-regimens, particularly if steroids are a component of their therapy.

Antineoplastic Combined Chemotherapy Protocols↗

New chemotherapy combinations with docetaxel in the treatment of patients with non-small cell lung cancer.

The modest antitumor activity and clinical benefit of conventional platinum-containing multidrug regimens in locally advanced and metastatic non-small cell lung cancer have provided the impetus for the development of novel combinations. The promising single-agent activity of docetaxel makes it an obvious candidate for incorporation into active programs. The Irish Clinical Oncology Research Group is conducting a phase I-II evaluation of a three-drug combination of docetaxel, ifosfamide, and cisplatin with lenograstim support in patients with stages III-IV non-small cell lung cancer. Preliminary results indicate that the regimen is feasible and tolerable up to a maximum tolerated dose level of 3,000 mg/m2 ifosfamide, 75 mg/m2 cisplatin, and 75 mg/ m2 docetaxel. The regimen appears to be quite active, with nine of 12 evaluable patients responding in the phase I component of the trial. This dose level is currently being explored in a phase II trial.

Adult↗

Breast cancer and pregnancy.

Sixteen of 194 premenopausal woman with breast cancer developed the disease in association with pregnancy. Eight were pregnant as diagnosis and eight were post-partum. There were significant delays in referral for surgical opinion and treatment among both groups. Two of the eight pregnant patients were diagnosed during the first trimester and one during the second trimester. The rest were at or close to term. Standard surgical therapy without irradiation was employed for early stage disease. Adjuvant chemotherapy posed some problems. One of the patients in the first trimester declined all treatment while the other opted for surgery only until after delivery. There was a favourable obstetrical outcome in all cases and survival for this group of patients is similar to that reported in the medical literature. None of the group had a further pregnancy. The incidence of breast cancer related to pregnancy in this premenopausal group was 8% with 1% occurring in the first trimester. This would mean three or four such cases per annum in Ireland.

Adult↗