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C O Granai

Publications and source records attributed to C O Granai.

At least 19 recordsLinked to original sources
PubMed2006

Does the platinum-free interval predict the incidence or severity of hypersensitivity reactions to carboplatin? The experience from Women and Infants' Hospital.

OBJECTIVES: Carboplatin (C) is a standard treatment for gynecologic cancers, but its use in recurrence is associated with an increased risk of hypersensitivity reactions (HSR) in those previously treated with C. However, there is no way to predict those at risk for a C-HSR. We sought to evaluate whether the platinum-free interval (PFI) was predictive of incidence and severity of HSRs. METHODS: Patients treated with C between 1/99 and 12/2005 were identified through our chemotherapy database. Records were reviewed in those receiving multiple C regimens or with C HSR. Severity was defined as mild or severe based on symptoms. RESULTS: 126 patients were identified who had multiple C regimens. 63 (50%) experienced C HSRs of which 36 (29%) were severe. The incidence of C HSR was 25.8% for PFI < 12 months and 56.5% if > or = 12 months (p=0.0023). The incidence of a severe C HSR significantly increased with time as well: 6.5% PFI < 12 months, 23.9% PFI 12-24 months and 47% PFI > or = 24 months (p=0.0091). Of those receiving a 3rd regimen of C, 8/8 had a HSR and these were severe in seven (88%). Of note, 60 patients received > 8 (range 9-19) cycles with the first C regimen, and none of the patients reacted after cycle 8. CONCLUSIONS: A duration of greater than 12 months between C regimens is associated with an increased risk of both any--and severe--HSR. Our data also suggests that upfront treatment with C beyond eight cycles is not associated with an increased risk of HSR.

Adult↗
PubMed2006

The prognostic significance of lower uterine segment involvement in surgically staged endometrial cancer patients with negative nodes.

OBJECTIVES: Endometrial cancer is the most common female genital malignancy in the United States. Stage is the most important prognostic factor. Other factors include grade, lymph-vascular space invasion (LVI), and myometrial invasion. Tumor location in the lower uterine segment (LUS) may also be important. LUS involvement correlates with nodal involvement, and nodal involvement is an important prognostic indicator. This study investigates the importance of LUS involvement in patients with pathologically negative nodes. METHODS: This was an IRB approved retrospective study. Data were collected for patients diagnosed with endometrial cancer from June 1999 to September 2004. Patients who underwent nodal evaluation with no evidence of nodal disease were eligible for analysis. The primary endpoint was progression-free survival. Secondary endpoints included recurrence rate and overall survival. Analysis was performed with the JMP5.1 statistical program. RESULTS: 285 patients were identified. 85 were excluded because they received postoperative care elsewhere. 3 charts were missing, and 15 pathology reports did not mention LUS. 147 of the remaining 182 subjects had negative nodes and formed the study population. 57% of these subjects had LUS involvement. Follow-up was similar for those with and without LUS involvement at 74 vs. 73 months respectively. PFS was similar at 70 and 63 months in those with and without LUS involvement (p=0.2). Recurrence correlated with LUS involvement on univariate analysis, however, not on multivariate analysis. CONCLUSIONS: In endometrial cancer patients with negative nodes, disease within the lower uterine segment does not imply a worse prognosis. The previously described implications of LUS involvement are likely due to the strong association of LUS disease with lymph node spread.

Aged↗
PubMed2006

Elevated body mass index does not increase the risk of palmar-plantar erythrodysesthesia in patients receiving pegylated liposomal doxorubicin.

OBJECTIVES: The dose-limiting toxicity of pegylated liposomal doxorubicin (PLD) is palmar-plantar erythrodysesthesia (PPE). Some physicians are reluctant to use this drug in overweight patients, postulating that larger size increases the likelihood of PPE. We sought to determine whether a correlation exists between body mass index (BMI) and the frequency or severity of skin reactions during PLD chemotherapy. METHODS: The records of all patients receiving PLD chemotherapy for gynecologic malignancy at our institution were reviewed for chemotherapy history, BMI at start of treatment, dose, infusion time, and adverse outcomes. Skin reaction sites, grade, and treatments were recorded. Possible predisposing factors were extracted, as well as the reason for drug discontinuation. RESULTS: Over 7 years, 103 patients were treated with PLD for gynecologic malignancies. 429 cycles were given, and PPE occurred in 36% of patients treated. Of those with PPE, reactions were grades 1, 2, or 3 in 54%, 32%, and 14% of patients, respectively. The BMI of patients with PPE (29.0) was not significantly different from that of patients without PPE (28.8). Analysis using finer subsets of weight also revealed no association. Finally, logistic regression revealed no relationship between BMI and rash grade. CONCLUSIONS: Elevated BMI does not appear to correlate with occurrence of PPE in our population. Of interest, among patients discontinuing PLD due to skin toxicity, 25% had clinical evidence of response. The identification of predisposing risk factors may help guide treatment decisions; however, elevated BMI does not appear to be such a risk factor.

Antibiotics, Antineoplastic↗
PubMed2006

All by itself.

Explore the source record for details and available documents.

CA-125 Antigen↗
PubMed2005

Inguinal sentinel node dissection versus standard inguinal node dissection in patients with vulvar cancer: A comparison of the size of metastasis detected in inguinal lymph nodes.

OBJECTIVE: The emergence of sentinel lymph node (SLN) technology has provided the ability for an in depth pathologic evaluation for the detection of metastasis to lymph nodes through the use of ultra-staging. The SLN has been shown to be predictive of the metastatic status of its nodal basin. More recently, SLN dissections have been employed in the evaluation of the inguinal lymphatic basins in patients with vulvar malignancies. We hypothesize that the average size of metastasis detected in non-palpable inguinal lymph nodes is smaller when detected through the use of SLN dissection and ultra-staging versus complete inguinal node dissection (CND). METHODS: This was an IRB approved retrospective study. The tumor registry database was searched to identify all patients diagnosed with a vulvar malignancy from 1990 to 2004. The records were reviewed to identify patients with inguinal lymph node metastasis. Only patients with non-palpable inguinal lymph nodes (metastasis 1 cm or less) were included in the analysis. All pathology slides were reviewed. The smallest metastatic foci of cells were measured from lymph nodes obtained through the traditional complete inguinal lymph node dissection (CND) and compared with the largest metastatic foci of cells detected in sentinel lymph node dissections. The mean size and standard deviation for each group was calculated and analyzed with a Mann-Whitney test. RESULTS: There were 336 inguinal node dissections performed in patients identified with a vulvar malignancy. SLN dissections were performed in 52 groins and CND in 284 groins. Fifty-eight patients were found to have metastatic disease to the inguinal lymph nodes. Thirty of these patients had no evidence of lymph node metastasis on clinical exam or at the time of their EUA. There were 7 groins with metastasis detected through an SLN and 23 groins through a CND. The mean size of the metastatic foci detected in the SLN group was 2.52 mm (SD 1.55) and in the CND group was 4.35 mm (SD 2.63). This was not statistically significant (P = 0.109). However, when comparing the detection of micrometastasis in each set, there was a significant difference (P = 0.02) in the detection of the size of metastasis detected with smaller cluster of cells detected in the SLN group. CONCLUSION: SLN dissection with ultra-staging allows for a more extensive pathologic examination of lymph nodes and may allow for the detection of smaller tumor foci than the traditional pathological examination of lymph nodes obtained from a CND. The clinical implication of the detection of these micrometastasis and smaller metastasis remains to be determined.

Aged↗
PubMed2003

Pathologic evaluation of inguinal sentinel lymph nodes in vulvar cancer patients: a comparison of immunohistochemical staining versus ultrastaging with hematoxylin and eosin staining.

OBJECTIVES: To evaluate the value of immunohistochemical (IHC) staining of inguinal sentinel lymph nodes (SLN) found to be negative for metastatic disease by ultrastaging with hematoxylin and eosin (H&E) staining. METHODS: An IRB approved study identified 29 patients who had undergone an inguinal sentinel lymph node dissection for squamous cell carcinoma of the vulva. All sentinel lymph nodes found to be negative for metastatic disease based on ultrastaging with H&E staining were reevaluated with pancytokeratin antibody (AE1/AE3) immunohistochemical (IHC) staining to detect micrometastasis. RESULTS: Twenty-nine patients with squamous cell carcinoma of the vulva underwent an inguinal sentinel node dissection. Nineteen patients had inguinal dissections negative for metastatic disease, 2 patients had bilateral inguinal metastasis, and 8 patients had unilateral inguinal metastasis. A total of 42 groin dissections with SLN biopsies were performed; 12 groins were positive for metastatic disease and 30 were negative based on ultrastaging with eosin and hematoxylin staining. A total of 107 sentinel lymph nodes (2.5 SLN per groin) were obtained, of which 18 SLN contained metastatic disease identified by ultrastaging and staining with H&E. Two SLN contained micrometastasis less than 0.3mm in size and 16 SLN contained metastasis greater than 2mm in size. Eighty-nine SLN found to be negative for metastasis by ultrastaging with H&E staining were also negative for micrometastasis on evaluation with pancytokeratin antibody AE1/AE3 IHC staining. CONCLUSIONS: The addition of immunohistochemical staining to ultrastaging with H&E staining in the pathologic evaluation of inguinal sentinel lymph nodes does not increase the detection of micrometastasis in patients with primary squamous cell carcinoma of the vulva.

Carcinoma, Squamous Cell↗
PubMed2003

What matters matter? P values, H values, leadership, and us.

Framed by the question "What matters matter?," this essay considers today's physicians' need for leadership, the principled road they embarked on, and the reasons to continue. Taken as a whole, the vast problems of health care seem unsolvable. Approached in small tangible steps, if not cure, could direction, even inspiration, appear? When people are sick, they look to physicians. By actually caring for patients, physicians have earned trust and learned, scientifically and artfully, about life in ways others cannot. Meaningful patient-centered care occurs at the junction of logical science and tenuous human needs: "p values" and "h values." Along with the privileged understanding gained from patients comes the responsibility to stand publicly for the rights of all patients to private moments. Standing up in these ways can never be easy; then again, it never was. It is the continued journey toward historic ideals. It is an imprecise place of struggle, where caring "leadership" has always been most needed, fulfilling and truly defining physicians. Despite today's seemingly insurmountable obstacles, in this place each physician can find ways to reenergize around what matters matter.

Humans↗
PubMed2002

Caelyx/Doxil for the treatment of metastatic ovarian and breast cancer.

Caelyx/Doxil is a novel pegylated liposomal formulation of the first-generation anthracycline, doxorubicin. The pharmacokinetics of this polyethylene-glycol-coated liposome are characterized by a reduced volume of distribution, a long intravascular circulating half-life and slow plasma clearance compared with free doxorubicin. This, coupled with a small vesicular size, uniquely promotes the localization of Caelyx/Doxil at tumor sites and explains its altered toxicity profile. The FDA and EMEA have approved its use for the treatment of AIDS-related Kaposi's sarcoma and, more recently, for recurrent epithelial ovarian cancer (EOC). Numerous investigations have focused on its use in the treatment of metastatic breast cancer, as well as recurrent squamous cell cervical carcinoma, soft tissue sarcoma, squamous head and neck cancers, prostate cancers and malignant gliomas. Ongoing clinical studies of combination regimens incorporating Caelyx/Doxil will further clarify its role in the treatment of advanced solid tumors.

Animals↗
PubMed2000

Phase II study of liposomal doxorubicin in platinum- and paclitaxel-refractory epithelial ovarian cancer.

PURPOSE: Stealth liposomal doxorubicin (Alzal Corp, Palo Alto, CA) has a slower clearance rate than free doxorubicin, resulting in sustained serum levels. Liposomal encapsulation also leads to increased concentration of drug in tumor tissue. Meta-analysis of previous studies has shown that doxorubicin has activity in epithelial ovarian cancer. The current study was developed to examine the activity of Stealth liposomal doxorubicin in platinum- and paclitaxel-refractory ovarian cancer. PATIENTS AND METHODS: Patients had epithelial ovarian cancer that either progressed on or recurred within 6 months of completion of platinum and paclitaxel chemotherapy. All patients had measurable disease. Stealth liposomal doxorubicin was administered at 50 mg/m(2) every 4 weeks as a 1-hour infusion. RESULTS: Eighty-nine patients were treated and included in an intent-to-treat analysis. There were 82 patients who were platinum and paclitaxel refractory and met all study criteria. There was one complete response and 14 partial responses, for a total response rate of 16.9% (95% confidence interval [CI], 9.1% to 24.6%). For platinum- and paclitaxel-refractory patients, the response rate was 18.3% (95% CI, 9.9% to 26.7%). Median time to progression was 19. 3 weeks for the entire population. Ten patients (11.2%) withdrew because of adverse events related to the drug (palmar-plantar erythrodysesthesia [PPE], n = 3; asthenia, n = 2; cardiac, n = 2; neutropenia, n = 1; stomatitis, n = 1; and edema, n = 1). There were no drug-related fatal events. There were only eight grade 4 adverse events attributable to the drug. Stomatitis, PPE, and skin lesions were managed with dose reductions and delays in most cases. CONCLUSION: Stealth liposomal doxorubicin has activity in refractory epithelial ovarian cancer. PPE and stomatitis can usually be managed by dose adjustment. The ease of administration makes this an attractive agent.

Adult↗
PubMed1999

Expectations about alternative therapies and women with gynecological cancer.

Women with gynecological cancers are exploring and using 'alternative medicine(s)', as are other cancer patients and much of Western society. On behalf of their patients, physicians must understand something of its history, terms, types, who uses it and why and where to find answers, as well as being prepared to open and engage in dialogue about alternative medicine with their patients.

Complementary Therapies↗
PubMed1998

Absence of estrogen and progesterone receptors in glassy cell carcinoma of the cervix.

OBJECTIVE: To evaluate the estrogen and progesterone receptor status of glassy cell carcinoma of the cervix to assess the possible implications of hormone replacement therapy in these patients. METHODS: The estrogen and progesterone receptor status of 13 glassy cell carcinomas was evaluated by immunohistochemistry using commercial monoclonal antibodies and a streptavidin-biotin detection system. RESULTS: No immunohistochemically detectable estrogen or progesterone receptor protein was present in tumor cells, although both receptors were identified in the adjacent normal cervical tissue. CONCLUSION: The absence of estrogen and progesterone receptors in glassy cell carcinoma suggests that this tumor would not be hormonally responsive and that these patients can be safely treated with hormone replacement therapy. Further studies are indicated to confirm this observation.

Adult↗
PubMed1997

S-Phase fraction, p53, and HER-2/neu status as predictors of nodal metastasis in early vulvar cancer.

OBJECTIVE: Our aim was to determine the value of the S-phase fraction, p53, and HER-2/neu status as predictors of inguinal nodal metastasis in early vulvar cancer. METHODS: The charts of 100 consecutive patients with invasive squamous cell cancer of the vulva were reviewed and a cohort of patients with clinical stage I or II disease treated primarily with radical surgery and inguinal node dissection was identified. Within this cohort, all node-positive patients were matched with node-negative controls by depth of invasion. Tumor from the 13 node-positive patients and 26 controls was then analyzed by flow cytometry and immunohistochemistry. RESULTS: The median value of the S-phase fraction was higher in tumor from patients with inguinal nodal metastasis (median, 18.2; 25th-75th percentile: 13.9-28.3) than in node-negative patients (median, 8.9; 25th-75th percentile: 5.4-15.6) (P = 0.01). The presence of the HER-2/neu immunopositivity was also found to be associated with nodal metastasis (OR 4.05, 95% CI 1.0-16.6), but we found no evidence that DNA index or the presence of p53 immunopositivity was associated with nodal metastasis. CONCLUSION: Early vulvar cancer patients with inguinal node metastasis have a significantly higher S-phase fraction and are more likely to have HER-2/neu immunopositivity when compared to those without nodal metastasis.

Carcinoma, Squamous Cell↗
PubMed1997

Prognostic value of clinical variables in ovarian cancer.

OBJECTIVE: To test the hypothesis that clinical variables, including the patient's symptoms, symptom severity, and co-morbidity, affect the survival rate in patients with ovarian cancer. METHODS: We reviewed the records of 137 cases of ovarian cancer diagnosed and treated between January 1987 and June 1992, and extracted data regarding patients' demographic characteristics, symptoms, medical co-morbidity, stage of disease, tumor histology and grade, treatment, and clinical course. RESULTS: Once cases of borderline tumors were excluded, the overall 3-year and 4-year mortality rate were 38% and 49%, respectively. There was an decrease in 4-year survival with more advanced symptom type ranging from 85% in asymptomatic women to 38% in women with complex symptoms (log rank, p = 0.005). Medical co-morbidity was not found to affect survival in the cohort studied. We performed multivariable analysis using a Cox proportional hazards model and confirmed that the symptom stage was highly prognostic even after controlling for FIGO stage, age and co-morbidity (p = 0.004). CONCLUSION: We found that clinical variables such as patient's symptoms, were associated with prognosis. Symptom classification is a necessary and important component in a system of prognostic stratification for ovarian cancer.

Adolescent↗
PubMed1996

Synchronous endometrioid tumors of the ovary and endometrium. A clinicopathologic study of 22 cases.

OBJECTIVE: To analyze a group of 22 patients with synchronous endometrioid tumors of the ovary and endometrium. STUDY DESIGN: A retrospective chart review was undertaken and information collected on patient age, parity, tumor grade and stage, presence of coexisting endometriosis and survival. Flow cytometry was determined from archival samples of the endometrial and ovarian tumors. RESULTS: The mean age at diagnosis was 52.8 years (range 36-71); mean parity was 1.05. With regard to the endometrial component, 68.2% were grade 1, 63.6% were stage I and, by flow cytometry, 62.5% were aneuploid. With regard to the ovarian lesions, 68.2% were grade 1, 68.2% were stage I, and 71.4% were aneuploid by flow cytometry. Twelve (54.5%) of 22 patients had pathologic evidence of coexisting endometriosis. Overall, three-year survival was 75%. All 11 patients with stage I disease at both sites were alive, without disease, at a mean follow-up of 34.9 months. CONCLUSION: Patients with synchronous endometrioid tumors of the endometrium and ovary are generally younger than reported for either endometrial adenocarcinomas or ovarian epithelial adenocarcinomas. They tend to be low grade and early stage and are frequently associated with endometriosis. Our data suggest that the survival of patients with synchronous primaries correlates with the stage of the individual tumors and that a second, synchronous primary does not adversely affect prognosis.

Adenocarcinoma↗
PubMed1995

Tumor angiogenesis as a prognostic factor in cervical carcinoma.

Angiogenesis, the induction of new capillaries and venules, has been associated with tumor growth. Increased tumor size and new vessel growth may further the opportunity for tumor cells to enter the circulation and potentiate metastatic disease. To investigate if tumor angiogenesis could serve as a prognostic factor in cervical carcinoma, we counted microvessels (capillaries and venules) in 29 patients with squamous cell carcinoma of the cervix. Surgical specimens were stained for endothelial cells specifically with Factor VIII to identify all vessels. The microvessels were counted by light microscopy (per 200 x field) in tumor sections with the highest population of microvessels. This was performed by two investigators without knowledge of patient outcome or extent of disease. Microvessel counts in patients with squamous cell carcinoma were significantly different from those of control subjects: 56 +/- 28.9 and 16.3 +/- 3.3 (P = 0.013). There was no correlation between microvessel count and node status, parametrial involvement, depth of invasion, or gross disease. Microvessel count was significantly correlated with vascular space involvement (P = 0.017). Four patients who developed recurrent disease within 1 year had high microvessel counts and yet were node negative and VSI negative at surgery. As shown by Folkman in breast cancer, angiogenesis may also be an independent predictor for recurrent disease in squamous cell carcinoma of the cervix. Microvessel counts could be of prognostic value in patients who do not have other risk factors for disease recurrence.

Adult↗