Biomedical subjects

Jennifer H Menell

Publications and source records attributed to Jennifer H Menell.

11 recordsLinked to original sources

PubMed2006

Phase II study of temozolomide plus pegylated interferon-alpha-2b for metastatic melanoma.

BACKGROUND: Temozolomide and interferon-alpha-2b (IFN-alpha-2b) are both active in melanoma. Therefore, the efficacy and safety of temozolomide in combination with pegylated IFN-alpha-2b in patients with metastatic melanoma without brain metastases was investigated. METHODS: Patients with histologically confirmed, unresectable, American Joint Committee on Cancer Stage IV melanoma were enrolled in an open-label, Phase II study. The primary endpoints were tumor response and safety. Patients received temozolomide (75 mg/m2/dayx6 weeks with a 2-week break between cycles) plus concomitant subcutaneous pegylated IFN-alpha-2b (0.5 microg/kg/wk, continuously). Treatment was continued until unacceptable toxicity or disease progression occurred. RESULTS: Thirty-five patients (median age, 55 years) with Stage IV melanoma and a median of 3 metastatic sites were enrolled and received a median of 1 cycle (i.e., 8 weeks) of therapy (range, 0-6 cycles). Eleven patients (31%) (95% confidence interval, 16% to 47%) had an objective tumor response, including 3 with clinical complete response durations of 6 months, 20 months, and 32+ months and 8 with partial responses. Three patients with a partial or mixed response were subsequently rendered free of clinically detectable disease with surgery. The median survival was 12 months with a median follow-up among survivors of 16 months. No patient developed brain metastases while receiving study treatment. Treatment was generally well tolerated. Hematologic toxicity consisted mainly of lymphopenia and leukopenia (National Cancer Institute Common Toxicity Criteria Grades 1-3); no Grade 4 hematologic toxicity was observed. CONCLUSIONS: The combination of temozolomide plus pegylated IFN-alpha-2b had antitumor activity and was well tolerated in patients with metastatic melanoma. Therefore, further study is warranted.

Adult↗

PubMed2005

Temozolomide plus thalidomide in patients with brain metastases from melanoma: a phase II study.

BACKGROUND: Temozolomide plus thalidomide is a promising oral combination regimen for the treatment of metastatic melanoma. The current Phase II study examined the efficacy and safety of this combination in chemotherapy-naive patients with brain metastases. METHODS: Patients with histologically confirmed metastatic melanoma and measurable brain metastases received temozolomide (75 mg/m2 per day for 6 weeks with a 2-week break between cycles) plus concomitant thalidomide (200 mg/day escalating to 400 mg/day for patients < 70 years or 100 mg/day escalating to 250 mg/day for patients > or = 70 years). The primary end point was tumor response in the brain assessed every 8 weeks. RESULTS: Twenty-six patients with a median age of 60 years were treated. All patients had progressive brain metastases: 16 were symptomatic and 25 had extensive extracranial metastases. Eight patients had received whole-brain radiotherapy, 4 had received stereotactic radiotherapy, and 8 had received craniotomy with resection of hemorrhagic lesions. Fifteen patients completed > or = 1 cycle (median, 1 cycle; range, 0-4 cycles), and 11 discontinued treatment before completing 1 cycle (7 for intracranial hemorrhage, 2 for pulmonary embolism, 1 for deep vein thrombosis, and 1 for Grade 3 rash). Of 15 patients assessable for response, 3 had a complete or partial response (12% intent to treat) and 7 had minor response or stable disease in the brain. However, 5 of these 10 patients had disease progression at extracranial sites. The median survival period was 5 months for all 26 patients and 6 months for the 15 assessable patients. CONCLUSIONS: Temozolomide plus thalidomide was an active oral regimen for patients with brain metastases from malignant melanoma.

Adult↗

PubMed2003

Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma.

PURPOSE: To further investigate the efficacy and safety of temozolomide plus thalidomide in patients with metastatic melanoma without brain metastases. PATIENTS AND METHODS: Patients with histologically confirmed advanced-stage metastatic melanoma were enrolled in an open-label, phase II study. The primary end point was response rate. Patients received temozolomide (75 mg/m2/d x 6 weeks with a 2-week rest between cycles) plus concomitant thalidomide (200 mg/d with dose escalation to 400 mg/d for patients < 70 years old, or 100 mg/d with dose escalation to 250 mg/d for patients >/= 70 years old). Treatment was continued until unacceptable toxicity or disease progression occurred. RESULTS: Thirty-eight patients (median age, 62 years) with stage IV (three patients with M1a, eight with M1b, and 26 with M1c) or stage IIIc (one patient) melanoma and a median of four metastatic sites were enrolled, and received a median of two cycles of therapy. Twelve patients (32%) had an objective tumor response, including one with an ongoing complete response of 25+ months' duration and 11 with partial responses. Five patients achieving partial response with a more than 90% reduction of disease were converted to a complete response with surgery. Treatment was generally well tolerated. Median survival was 9.5 months (95% confidence interval, 6.05 to 19.38 months), with a median follow-up among survivors of 24.3 months. CONCLUSION: The combination of temozolomide plus thalidomide seems to be a promising and well-tolerated oral regimen for metastatic melanoma that merits further study.

Adult↗

PubMed2003

The use of MRI in the diagnosis and management of a bulky cervical carcinoma.

BACKGROUND: In the treatment of gynecologic cancer, surgical planning depends on the site and extent of disease. The evaluation of the origin of a large pelvic mass with combined pelvic examination and ultrasound is often adequate. However, the following case report illustrates the utility of magnetic resonance imaging (MRI) when sonographic findings are indeterminate and the origin of a pelvic mass is unclear. CASE: A 73-year-old woman presented for her first gynecologic exam in over 40 years. On speculum examination the cervix was not visible. A large, mobile pelvic mass was palpated during physical examination. Pelvic ultrasound revealed a large, cystic pelvic mass thought to be ovarian in origin. Surgery for presumed ovarian carcinoma was planned. Because a vaginal Pap smear revealed squamous-cell carcinoma, MRI was performed for further evaluation. MRI demonstrated a blood distended uterus with a large cervical tumor obstructing the endocervical os. After cervical dilatation under sonographic guidance, evacuation of the hematometrium was performed. Multiple biopsies of the cervix confirmed the diagnosis of a bulky Stage IIA squamous-cell carcinoma of the cervix. The patient was subsequently treated with concomitant chemotherapy and radiation therapy. Follow-up MRI demonstrated an excellent treatment response. Modified radical hysterectomy was performed demonstrating very small residual tumor. CONCLUSIONS: Magnetic resonance imaging, through multiplanar capabilities and high-contrast resolution, is a valuable tool that can assist the clinician in the evaluation, diagnosis, and management of challenging gynecologic malignancies.

Aged↗

PubMed2003

Breast lesions detected with MR imaging: utility and histopathologic importance of identification with US.

PURPOSE: To determine the utility and histopathologic importance of ultrasonographic (US) depiction of breast lesions detected with magnetic resonance (MR) imaging. MATERIALS AND METHODS: Retrospective review was performed of 654 consecutive breast MR examinations performed from November 1999 to February 2001. This yielded 64 patients with 93 suspicious, nonpalpable, mammographically occult lesions evident on MR images and recommended for biopsy, for which directed US assessment was performed. Images, pathologic records, and medical records of these patients were reviewed for imaging findings, patient demographics, and histopathologic findings from subsequent biopsy. Statistical analysis was performed with the Fisher exact test. RESULTS: The median size of MR abnormalities was 0.9 cm (range, 0.3-5.0 cm). The pattern of enhancement was a focal mass in 76 (82%) lesions and nonmass in 17 (18%). A US correlate was identified in 21 (23%) lesions detected with MR--19 (25%) of 76 focal mass and two (11%) of 17 nonmass lesions. Carcinoma was found in nine (43%) of these lesions, of which seven (78%) were invasive carcinoma and two (22%) were ductal carcinoma in situ (DCIS). Among the lesions without a US correlate, 10 (14%) yielded carcinoma, of which five (50%) were invasive carcinoma and five (50%) were DCIS. The frequency of cancer was significantly higher for lesions that were detected with MR imaging and had a US correlate than for those that did not have a US correlate (43% vs 14%, P =.01). Overall, 19 (20%) lesions detected with MR imaging and examined with US yielded carcinoma at biopsy, and nine (47%) malignant lesions were seen on US images. US depicted seven (58%) of 12 invasive cancers and two (29%) of seven instances of DCIS. CONCLUSION: The likelihood of carcinoma was significantly higher among lesions with a US correlate (43% carcinoma) than lesions without a US correlate (14% carcinoma).

Biopsy↗

PubMed2003

MR imaging findings in the contralateral breast of women with recently diagnosed breast cancer.

OBJECTIVE: The purpose of this study was to determine the frequency and positive predictive value of biopsy performed on the basis of MR imaging findings in the contralateral breast in women with recently diagnosed breast cancer. MATERIALS AND METHODS: We performed a retrospective review of records of 1336 consecutive breast MR imaging examinations over a 2-year period. Of these examinations, 223 imaged the asymptomatic, mammographically normal contralateral breast in women whose breast cancer was diagnosed within 6 months preceding MR imaging. Records of these 223 examinations were reviewed to determine the frequency of recommending contralateral breast biopsy and the biopsy results. RESULTS: Contralateral breast biopsy was recommended in 72 (32%) of 223 women and performed in 61 women. Cancer occult to mammography and physical examination was detected by MR imaging in 12 women, constituting 20% (12/61) of women who underwent contralateral biopsy and 5% (12/223) of women who underwent contralateral breast MR imaging. Among these 12 cancers, six (50%) were ductal carcinoma in situ (DCIS) and six (50%) were infiltrating carcinoma. The median size of infiltrating carcinoma was 0.5 cm (range, 0.1-1.0 cm). Contralateral biopsy revealed benign (n = 31) or high-risk (n = 18) lesions in 49 women, constituting 80% (49/61) of women who underwent contralateral biopsy and 22% (49/223) of women who underwent contralateral MR imaging. CONCLUSION: In women with recently diagnosed breast cancer, MR imaging of the contralateral breast led to a biopsy recommendation in 32%. Cancer was found in 20% of women who underwent contralateral breast biopsy and in 5% of women who underwent contralateral breast MR imaging.

Aged↗

PubMed2002

Temozolomide plus thalidomide in patients with advanced melanoma: results of a dose-finding trial.

PURPOSE: To establish a safe and tolerated regimen of an oral cytotoxic agent, temozolomide, and a cytostatic agent, thalidomide, in patients with unresectable stage III or IV malignant melanoma. PATIENTS AND METHODS: Patients with unresectable stage III or IV melanoma without brain metastases were entered successively onto four treatment cohorts: level 1, temozolomide 50 mg/m(2)/d for 6 weeks followed by a 4-week break; levels 2, 3, and 4, temozolomide 75 mg/m(2)/d for 6 weeks followed, respectively, by breaks of 4, 3, and 2 weeks. Thalidomide was started at 200 mg/d, and escalated to a maximum dose of 400 mg/d. Safety was assessed at weeks 2 and 4 and every 4 weeks thereafter; tumor response was evaluated every 8 to 10 weeks. RESULTS: Twelve patients were enrolled, three on each cohort. Therapy was generally well tolerated on all of the treatment schedules. Thalidomide at a dose of 400 mg/d was well tolerated in patients younger than 70, and 200 mg/d was well tolerated in older patients. The most common adverse events were grade 2 or 3 constipation and neuropathy, which were attributed to thalidomide. Five major responses (one complete, four partial) were documented, all at dose levels 2 to 4. Three of the five responding patients were in the over-70 age group. The median duration of response was 6 months (range, 4 to 17+ months), and the median overall survival was 12.3 months (range, 4 to 19+ months). CONCLUSION: The combination of temozolomide and thalidomide was well tolerated and had antitumor activity in patients with advanced melanoma, including elderly patients over 70 years old.

Aged↗

PubMed2002

Breast imaging reporting and data system (BI-RADS).

The Breast Imaging Reporting and Data System (BI-RADS) lexicon was developed by the American College of Radiology to standardize mammographic reporting. The BI-RADS lexicon defines terms to describe abnormalities on mammograms, and it defines final assessment categories that are predictive of the likelihood of malignancy. Although the lexicon is clinically useful and facilitates communication and research, there is still substantial interobserver variability in its application. Lexicons for breast sonography and breast MRI are in progress.

Breast Diseases↗

PubMed2002

Breast lesions detected on MR imaging: features and positive predictive value.

OBJECTIVE: The purpose of this study was to analyze features of breast lesions detected on MR imaging that had subsequent biopsy and to determine the positive predictive value (PPV) of these features. MATERIALS AND METHODS: Retrospective review was performed of 100 consecutive solitary MR imaging-detected breast lesions that had MR imaging-guided needle localization and surgical excision. We described lesions, using terms found in a proposed breast MR imaging lexicon. Histologic findings were reviewed. RESULTS: Carcinoma was identified in 25 lesions (25%), including ductal carcinoma in situ (DCIS) in 13 (52%) and infiltrating carcinoma in 12 (48%). Carcinoma was found in 15 (25%) of 60 masses versus 10 (25%) of 40 nonmass lesions; most malignant masses (73%) were infiltrating carcinoma, whereas most malignant nonmass lesions (90%) were DCIS. The features with the highest PPV were spiculated margin (80% carcinoma), rim enhancement (40% carcinoma), and irregular shape (32% carcinoma) for mass lesions and segmental (67% carcinoma) or clumped linear and ductal enhancement (31% carcinoma) for nonmass lesions. Visually assessed kinetic patterns were not significant predictors of carcinoma, but washout was present in 70% of infiltrating carcinomas versus 9% of DCIS lesions (p < 0.01). Carcinoma was present in 17 (19%) of 88 lesions classified as suspicious versus eight (67%) of 12 lesions classified as highly suggestive of malignancy (p = 0.001). CONCLUSION: Among MR imaging-detected breast lesions referred for biopsy, carcinoma was found in 25%, of which half were DCIS. Features with the highest PPV were spiculated margin, rim enhancement, and irregular shape for mass lesions and segmental or clumped linear and ductal enhancement for nonmass lesions. Final assessment categories were significant predictors of carcinoma.

Adult↗

PubMed2002

To excise or to sample the mammographic target: what is the goal of stereotactic 11-gauge vacuum-assisted breast biopsy?

OBJECTIVE: This study was undertaken to determine whether complete percutaneous excision rather than sampling of the mammographic target conveys any significant advantage or disadvantage at stereotactic 11-gauge vacuum-assisted biopsy. MATERIALS AND METHODS: A retrospective review was performed of 788 consecutive solitary lesions in which the mammographic target was excised (n = 466) or sampled (n = 322) at stereotactic 11-gauge vacuum-assisted biopsy. Medical records and histologic findings were reviewed to determine the frequency of sparing surgery, discordance, histologic underestimation, rebiopsy, complete histologic removal of cancer, and complications. Statistical comparisons were made using the Fisher's exact test. RESULTS: Complete excision rather than sampling of the mammographic target was associated with a significantly lower frequency of discordance (1/466, 0.2% vs 8/322, 2.5%; p = 0.004) and a trend toward fewer ductal carcinoma in situ underestimates (4/59, 6.8% vs 12/60, 20.0%; p = 0.07). Complete histologic removal of cancer was significantly more likely if the mammographic target was excised rather than sampled (19/91, 20.9% vs 7/106, 6.6%; p = 0.006); however, among 91 cancers in which the mammographic target was excised, surgery revealed residual cancer in 72 (79.1%). Complete excision rather than sampling of the mammographic target yielded no significant differences in the frequency of sparing surgery, atypical ductal hyperplasia underestimates, rebiopsy, or complications. CONCLUSION: Complete excision rather than sampling of the mammographic target was associated with lower frequencies of discordance and ductal carcinoma in situ underestimation but had no other advantage or disadvantage. Among cancers in which the mammographic target was excised, surgery revealed residual cancer in almost 80%.

Adult↗

PubMedDate not supplied

Determination of the presence and extent of pure ductal carcinoma in situ by mammography and magnetic resonance imaging.

The purpose of this study was to compare the ability of magnetic resonance imaging (MRI) and mammography to determine the presence and extent of ductal carcinoma in situ (DCIS). Retrospective review of medical records of women who underwent MRI and mammographic examination during a 23-month period revealed 39 sites of pure DCIS in 33 breasts of 32 women. No invasive or microinvasive tumor was found. Women ranged in age from 34 to 79 years (mean age 53 years). In these 33 breasts, both MRI and mammography were done before surgery. Reports and images of mammography and MRI were reviewed to determine if each study was positive for the presence of single or multiple sites of DCIS and the imaging patterns associated with these sites. Of 33 breasts involved, DCIS was discovered by MRI alone in 21 (64%), by both MRI and mammography in 8 (24%), and by mammography alone in 1 (3%); in 3 breasts (9%), DCIS was found at mastectomy without findings on mammography or MRI. MRI had significantly higher sensitivity than mammography for DCIS detection (29/33=88% versus 9/33=27%, p<0.00001). Multiple sites of disease were present in five breasts; these were better demonstrated with MRI in three, mammography in one, and equally by both in one. The predominant enhancement pattern of DCIS on MRI was linear/ductal in 18 of 29 breasts (62%); mammography found calcifications associated with DCIS in 8 of 9 (89%). The nuclear grade of DCIS found with MRI and mammography was similar; size of lesions was larger on MRI; breast density did not impact results. In this study, MRI was significantly more sensitive than mammography in DCIS detection. In women with known or suspected DCIS, MRI may have an important role to play in assessing the extent of disease in the breast.

Adult↗