PubMed Health⌕ Search

Biomedical subjects

D C Doval

Publications and source records attributed to D C Doval.

At least 19 recordsLinked to original sources

First-line gemcitabine versus epirubicin in postmenopausal women aged 60 or older with metastatic breast cancer: a multicenter, randomized, phase III study.

BACKGROUND: This randomized, phase III study compared the efficacy and safety of first-line gemcitabine versus epirubicin in the treatment of postmenopausal women with metastatic breast cancer (MBC). PATIENTS AND METHODS: Patients aged > or = 60 years (median 68 years) with clinically measurable MBC received either gemcitabine 1200 mg/m(2) or epirubicin 35 mg/m(2) on days 1, 8, and 15 of a 28-day cycle. RESULTS: Of 410 patients entered, 397 (198 gemcitabine and 199 epirubicin) were randomized and qualified for the time to progressive disease (TTP) and survival analyses. Total cycles administered in 185 gemcitabine and 192 epirubicin patients, respectively, were 699 (mean 3.5, range 0-12) and 917 (mean 4.6, range 0-10). Epirubicin demonstrated statistically significant superiority in TTP (6.1 and 3.4 months, P=0.0001), overall survival (19.1 and 11.8 months, P=0.0004), and independently assessed response rate (40.3% and 16.4% in 186 and 183 evaluable patients, P <0.001). For gemcitabine (n=190) and epirubicin (n=192), respectively, common WHO grade 3/4 toxicities were neutropenia (25.3% and 17.9%) and leukopenia (14.3% and 19.3%). Of the 28 on-study deaths (17 gemcitabine, 11 epirubicin), three were considered possibly or probably related to treatment (gemcitabine). CONCLUSIONS: Postmenopausal women > or =60 years of age with MBC tolerate chemotherapy well. In this study, epirubicin was superior to gemcitabine in the treatment of MBC in women age > or =60, confirming that anthracyclines remain important drugs for first-line treatment of MBC.

Aged↗

A phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer.

The primary objective of this study was to determine the response rates of the gemcitabine and cisplatin combination in unresectable gall bladder cancer patients. The secondary objectives were to evaluate the toxicity, time to progressive disease, and overall survival. Chemonaïve patients with histologically proven, unresectable bidimensionally measurable gall bladder cancer were enrolled into this study. All patients were required to have a Zubrod's performance status <or=2, no prior radiotherapy, and adequate major organ function. Patients received gemcitabine (1000 mg x m(-2) intravenously over 30-60 min) on days 1 and 8, and cisplatin (70 mg x m(-2) intravenously over 2 h) on day 1, every 21 days. Response assessment was done by a CT scan after every other cycle of chemotherapy. In all, 30 patients were eligible for efficacy and toxicity analysis. There were four (13.3%) complete responders, seven (23.3%) partial responders, and seven (23.3%) with stable disease, with four (13.2%) patients showing disease progression. The median time to progression was 18 weeks (95% confidence interval (CI) 14-24 weeks), and the median duration of response was 13.5 weeks (range 5.5-104 weeks). The median overall survival was 20 weeks (95% CI 14-31 weeks), with 1-year survival rate of 18.6%. WHO grade 3 or 4 anaemia was seen in seven (23.3%) and four (13.3%) patients, respectively. Five (16.6%) patients each experienced grade 3 or 4 neutropenia, and grade 3 or 4 thrombocytopenia was seen in three (10%) and two (6.6%) patients, respectively. The present study shows that gemcitabine/cisplatin combination is well tolerated and active in advanced unresectable gall bladder cancer.

Adult↗

Isolated hypoglossal nerve palsy due to skull base metastasis from breast cancer.

We describe a 44-year-old woman who presented with an isolated unilateral hypoglossal nerve paralysis caused by a skull base metastasis from breast cancer. The patient had a modified radical mastectomy followed by local radiotherapy and adjuvant chemotherapy. Fourteen months later she presented with difficulty in speaking. Physical examination revealed an isolated left hypoglossal nerve paralysis. The MRI scan showed a mass lesion involving the left occipital condyle extending into hypoglossal canal.

Adult↗

Efficacy and safety of granulocyte macrophage-colony stimulating factor (GM-CSF) on the frequency and severity of radiation mucositis in patients with head and neck carcinoma.

PURPOSE: Based on the clinical evidence of mucosal protection by GM-CSF during cytotoxic chemotherapy, a pilot study was undertaken to determine the safety and mucosal reaction of patients receiving GM-CSF while undergoing definitive conventional fractionated radiotherapy in head and neck carcinoma. METHODS AND MATERIALS: Patients were considered eligible if buccal mucosa and oropharynx were included in the teleradiation field. Ten adult patients with squamous cell carcinoma of head and neck (buccal mucosa--8 and posterior 1/3 tongue--2) were entered into the trial. Radiation therapy was delivered with telecobalt machine at conventional 2 Gy fraction and 5 fractions/week. The radiation portals consisted of two parallel opposing lateral fields. GM-CSF was given subcutaneously at a dose of 1 microg/kg body weight, daily, after 20 Gy until the completion of radiation therapy. Patients were evaluated daily for mucosal reaction, pain, and functional impairment. RESULTS: The median radiation dose was 66 Gy. Eight patients received > or = 60 Gy. The tolerance to GM-CSF was good. All 10 patients completed the planned daily dose of GM-CSF without interruption. Mucosal toxicity was Grade I in four patients till the completion of radiotherapy (dose range 50-66 Gy). Six patients developed Grade II reaction, fibrinous mucosal lesions of maximum size 1.0-1.5 cm, during radiotherapy. None developed Grade III mucositis. The maximum mucosal pain was Grade I during GM-CSF therapy. In two patients after starting GM-CSF the pain reduced in intensity. Functional impairment was mild to moderate. All patients were able to maintain adequate oral intake during the treatment period. Total regression of mucosal reaction occured within 8 days following completion of radiotherapy. CONCLUSIONS: GM-CSF administration concurrently with conventional fractionated radiotherapy was feasible without significant toxicity. The acute side effects of radiotherapy namely mucositis, pain, and functional impairment were nil to minimal. The results are suggestive of mucosal protection by GM-CSF during radiotherapy and warrants further study in randomized double blind trial.

Adult↗

Synovial sarcoma of the neck.

Primary synovial sarcoma of the head and neck region is a rare tumor. This report describes seven cases of primary synovial sarcomas, of which two were in the parapharyngeal region, two in the supraclavicular region, and one each in the hypopharynx, sternocleidomastoid and submandibular regions. Clinical presentations, radiological findings, histopathology and management are reviewed. All patients received multimodal therapy using aggressive surgery, radiotherapy and chemotherapy. Five of the patients are alive and disease free after 24-108 months of follow-up. Achievement of locoregional control appears to be the hallmark of successful therapy.

Adolescent↗

Osteosarcoma of the jaw bones.

Osteosarcoma of the jaw bone is comparatively rare and accounts for about 6.5% of all osteosarcomas. We treated eight cases of osteosarcoma of the jaw bone involving the mandible and maxilla in equal proportions between 1986-1992. The median age was 31 years and male: female ratio was 5:3. Swelling and bony expansion were the most common presentations. Radiologically six patients had lytic lesions, and histopathologically they were osteoblastic (n = 4), chondroblastic (n = 3) and fibroblastic (n = 1). Three patients, two with mandibular and one with maxillary osteosarcoma underwent radical surgery and six courses of cisplatinum-based chemotherapy. All were alive and disease free 24, 30, and 54 months after treatment. Histologically all three were chondroblastic. Five patients had incomplete or palliative treatment. All patients died of progressive or locally recurrent disease within 2 years.

Adult↗

Cardiac metastasis from carcinoma breast--a case report.

Secondary neoplasms of the heart are more common than primary tumours. Metastasis occurs most commonly from bronchogenic carcinoma followed by lymphoma and carcinoma breast. Most often cardiac metastasis go undetected as they are asymptomatic and occurs as a terminal event. A 51 year old lady who developed cardiac metastasis from carcinoma breast diagnosed during life is reported with brief review of the literature.

Bone Neoplasms↗

Magliant melanoma of the oral cavity: report of 14 cases from a regional cancer centre.

Fourteen patients with oral mucosal malignant melanomas seen at a regional cancer centre over a 10-year period were analysed. All the patients presented with symptoms of short duration, with extensive local disease at initial evaluation in 11 patients. The palate was the commonest site involved. Ten patients had regional nodal disease and of these four also had distant metastases to the liver and/or the lung. Coincidental melanosis was identified clinically in three patients and histologically confirmed in two patients. Only four patients underwent radical surgery. Of the five patients who received DTIC-based chemotherapy, only one achieved a complete response. No significant correlation between stage of the disease at presentation, histological features or type of treatment and survival could be seen as the number of cases is small.

Adult↗

Extrapolated response dose as a potential tool in radiotherapy and chemo-radiotherapy of head and neck cancers.

An analysis of head and neck cancer patients treated by radiotherapy (RT) alone (114 patients) and by chemo-radiotherapy (RT + CT) (115 patients) was carried out; the doses varied from 40-77 Gy and 35-71 Gy in RT and RT + CT groups respectively. The chemotherapy (CT) (induction/concurrent) drugs used were 5-FU, cisplatin, methotrexate either single or in combination. Extrapolated response dose values were evaluated with alpha/beta values of 10, 2.5 and 6 Gy for acute, late complications and tumour response, respectively. Dose enhancement factor (DEF) and Therapeutic gain factor (TGF) values were evaluated on the basis of ERD for patients receiving 5-FU RTCT (72 patients). ERD vs late complication rate and response rate curves were drawn for RT, RT + CT (< 7 cycles), RT + CT (> 6 cycles) and RT + CT (cumulative). DEF values for response rate were 0.95, 0.95 and 0.82 for the three RT + CT groups respectively. Similarly DEF values for late complication rate were evaluated as 0.87, 0.93 and 0.88. TGF values for RT + CT were 1.09, 1.02 and 0.93. TGF values indicated lack of significant influence of CT on clinical outcome. The correlation of ERD with late complication, response and status at last follow up (NED) was statistically significant for both groups (P < 0.01). ERD did not correlated with acute complication in RT group (P > 0.01). From the present analysis, in RT + CT treatments of head and neck cancers, an ERD value of 69 Gy is suggested as the limit for an acceptable 5% late complication rate.

Combined Modality Therapy↗

Pre leukemic granulocytic sarcoma of vagina. A case report with review of literature.

Granulocytic sarcoma is an extramedullary tumor of malignant granulocytic progenitor cells, that may precede the onset of acute myeloid leukemia or appear during the leukemic manifestation or blastic crisis of chronic myeloproliferative disorders. We describe a case of granulocytic sarcoma of vagina in a 27 year old woman treated with local radiotherapy. After seven months of follow up she developed acute myeloid leukemia. The case has been presented in view of its rarity and discussed in light of the available literature.

Adult↗

Adult paratesticular sarcomas: a report of eight cases.

Eight adult paratesticular sarcomas seen at a Regional Cancer Centre over a 7-year period are described. There were three cases of rhabdomyosarcoma (RMS), three cases of leiomyosarcoma (LMS), and two cases of liposarcoma (LS). The RMS occurred in a younger age group (3rd decade) than the LMS and LS (6th and 7th decades). Most of our patients presented with advanced disease after orchiectomy at other hospitals, three with recurrent or residual disease and four with metastasis. The single patient with RMS who received intensive adjuvant therapy is free of disease at 84 months in spite of the advanced stage at presentation. All three patients with LMS had an unfavourable clinical course. Both the patients with LS had well differentiated (WD) tumours and presented with recurrences, one over several years, following initial local excisions. The necessity for early adequate surgical and adjuvant therapy and the need for a uniform treatment policy are discussed.

Adult↗