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1.  A Double-Blind, Randomized Phase II Study to Evaluate the Safety and Efficacy of Acetyl-L-Carnitine in the Prevention of Sagopilone-Induced Peripheral Neuropathy 
The Oncologist  2013;18(11):1190-1191.
Background.
Peripheral neuropathy (PN) is a recognized side effect of microtubule-targeting agents and the most clinically relevant toxicity observed with the epothilone sagopilone (SAG). Studies suggest that acetyl-L-carnitine (ALC) may prevent chemotherapy-induced PN. We conducted a prospective, placebo (PBO)-controlled, double-blind, randomized trial to investigate the safety and efficacy of ALC for the prevention of SAG-induced PN.
Methods.
Patients with ovarian cancer (OC) or castration-resistant prostate cancer (CRPC) and no evidence of neuropathy received SAG (16 mg/m2 intravenously over 3 hours every 3 weeks) with ALC (1,000 mg every 3 days) or placebo (PBO). The primary endpoint was incidence of PN within six or fewer cycles in both treatment groups.
Results.
Overall, 150 patients enrolled (98 OC patients, 52 CRPC patients), with 75 per treatment arm. No significant difference in overall PN incidence was observed between treatment arms. The incidence of grade ≥3 PN was significantly lower in the ALC arm in OC patients. Median duration of neuropathy was similar between treatment arms. The best overall response (according to the modified Response Evaluation Criteria in Solid Tumors), response according to tumor markers, time-to-event variables, and discontinuations because of adverse events (AEs) were comparable between treatment arms.
Conclusion.
Administration of ALC with SAG did not result in a significant difference in overall PN incidence compared with a PBO. OC patients in the SAG/ALC arm had a significantly lower incidence of grade 3 or 4 PN compared with OC patients in the SAG/PBO arm.
doi:10.1634/theoncologist.2013-0061
PMCID: PMC3825303  PMID: 24105751
2.  Lymphocele and Ovarian Cancer: Risk Factors and Impact on Survival 
The Oncologist  2012;17(9):1198-1203.
This retrospective study describes the incidence, impact on survival, and the risk factors for symptomatic lymphoceles in patients with ovarian cancer.
Learning Objectives
After completing this course, the reader will be able to: Identify risk factors for lymphoceles after cytoreductive surgery in ovarian cancer.Describe the impact of lymphocleles on outcomes in women with ovarian cancer.
This article is available for continuing medical education credit at CME.TheOncologist.com
Introduction.
We describe the incidence, impact on survival, and the risk factors for symptomatic lymphoceles in patients with ovarian cancer.
Methods.
This retrospective study includes patients with ovarian cancer who had complete cytoreductive surgery and para-aortic and pelvic lymphadenectomy performed in our institute from 2005 to 2011. Patients were classified into two groups: patients with symptomatic lymphoceles and a control group.
Results.
During the study period, 194 patients with epithelial ovarian cancer underwent cytoreductive surgery and a lymphadenectomy without macroscopic residual disease. Fifty-four patients had symptomatic lymphoceles (28%). In the multivariate analysis, only supraradical surgery was significantly and independently associated with the risk of symptomatic lymphoceles occurring postoperatively. Median follow-up was 24.8 months (range, 1–74 months). Survival rates were not significantly different between the symptomatic lymphocele group and the control group. Two-year disease-free survival rates were 54% for the lymphocele group and 48% for the control group. Two-year overall survival rates were 90% for the lymphocele group and 88% for the control group.
Conclusions.
Symptomatic lymphoceles occur frequently after cytoreductive surgery in ovarian cancer. Supraradical surgery is an independent risk factor. The occurrence of symptomatic lymphoceles does not decrease survival. Nevertheless, further studies are needed to reduce the risk of lymphoceles in such patients.
doi:10.1634/theoncologist.2012-0088
PMCID: PMC3448413  PMID: 22707515
Lymphadenectomy; Ovarian cancer; Lymphocele; Cytoreductive surgery; Survival
3.  Randomized Multicenter and Stratified Phase II Study of Gemcitabine Alone Versus Gemcitabine and Docetaxel in Patients with Metastatic or Relapsed Leiomyosarcomas: A Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) French Sarcoma Group Study (TAXOGEM study) 
The Oncologist  2012;17(9):1213-1220.
This randomized multicenter phase II study aimed to evaluate the efficacy and toxicity of single-agent gemcitabine versus gemcitabine plus docetaxel as second-line therapy for patients with metastatic or relapsed leiomyosarcoma. Patients were stratified by the leiomyosarcoma's site of origin (uterine versus nonuterine).
Background.
This study aimed to evaluate the efficacy and toxicity of single-agent gemcitabine versus gemcitabine plus docetaxel as second-line therapy in patients with uterine and nonuterine leiomyosarcoma (LMS).
Patients and Methods.
Patients had metastatic or unresectable LMS and had received one prior anthracycline-based regimen. A total of 90 patients received either single-agent gemcitabine (arm A; gemcitabine, 1,000 mg/m2 i.v. for 100 minutes on days 1, 8, and 15 of a 28-day cycle) or a combination of gemcitabine and docetaxel (arm B; gemcitabine, 900 mg/m2 i.v. for 90 minutes on days 1 and 8, plus docetaxel, 100 mg/m2 i.v. for 1 hour on day 8 of a 21-day cycle with lenograstim). The primary endpoint was the objective response rate.
Results.
The objective response rates were 19% and 24% in arm A (gemcitabine) and arm B (gemcitabine plus docetaxel), respectively, for patients with uterine LMS. For patients with nonuterine LMS, the objective response rates were 14% and 5% for arms A and B, respectively. The median progression-free survival times for arms A and B were 5.5 months and 4.7 months, respectively, for patients with uterine LMS. For patients with nonuterine LMS, the median progression-free survival times were 6.3 months and 3.8 months for arms A and B, respectively. One toxic death occurred in arm B.
Conclusions.
Both single-agent gemcitabine and gemcitabine plus docetaxel were found to be effective second-line therapies for leiomyosarcomas, with a 3-month progression-free survival rate of 40% for LMS with both uterine and nonuterine sites of origin. Single-agent gemcitabine yielded results similar to those of gemcitabine plus docetaxel in this trial, but patients using single-agent gemcitabine experienced less toxicity.
doi:10.1634/theoncologist.2011-0467
PMCID: PMC3448415  PMID: 22907974
Leiomyosarcoma; Chemotherapy; Docetaxel; Gemcitabine
4.  Low-Dose-Rate Definitive Brachytherapy for High-Grade Vaginal Intraepithelial Neoplasia 
The Oncologist  2011;16(2):182-188.
The efficacy and safety results of treatment with low-dose-rate vaginal brachytherapy for grade 3 vaginal intraepithelial neoplasia over a 25-year period at Gustave Roussy Institute are presented. This treatment was found to be both safe and effective.
Learning Objectives
After completing this course, the reader will be able to: Utilize data supporting the efficacy of low-dose definitive brachytherapy to inform clinical decisions about treating women with high-grade vaginal intraepithelial neoplasia.Implement methods for delivering low-dose definitive brachytherapy that minimize toxicity.Communicate to patients the type and incidence of toxic events associated with low-dose definitive brachytherapy.
This article is available for continuing medical education credit at CME.TheOncologist.com
Background.
Treatment of high-grade vaginal intraepithelial neoplasia (VAIN) is controversial and could include surgical excision, topical medication, brachytherapy, or other treatments. We report the results of low-dose-rate (LDR) vaginal brachytherapy for grade 3 VAIN (VAIN-3) over a 25-year period at Gustave Roussy Institute.
Patients and Methods.
We retrospectively reviewed the files of all patients treated at Gustave Roussy Institute for VAIN-3 since 1985. The treatment consisted of LDR brachytherapy using a personalized vaginal mold and delivered 60 Gy to 5 mm below the vaginal mucosa. All patients had at least an annual gynecological examination, including a vaginal smear.
Results.
Twenty-eight patients were eligible. The median follow-up was 41 months. Seven patients had a follow-up <2 years, and the median follow-up for the remaining 21 patients was 79 months. The median age at brachytherapy was 63 years (range, 38–80 years). Twenty-six patients had a history of VAIN recurring after cervical intraepithelial neoplasia and 24 had a previous hysterectomy. The median brachytherapy duration was 4.5 days. Median doses to the International Commission of Radiation Units and Measurements rectum and bladder points were 68 Gy and 45 Gy, respectively. The median prescription volume (60 Gy) was 74 cm3. Only one “in field” recurrence occurred, corresponding to a 5- and 10-year local control rate of 93% (95% confidence interval, 70%–99%). The treatment was well tolerated, with no grade 3 or 4 late toxicity and only one grade 2 digestive toxicity. No second cancers were reported.
Conclusion.
LDR brachytherapy is an effective and safe treatment for vaginal intraepithelial neoplasia.
doi:10.1634/theoncologist.2010-0326
PMCID: PMC3228085  PMID: 21262875
Vaginal neoplasms; Carcinoma in situ; Cervical intraepithelial neoplasia; Brachytherapy
5.  Prognosis and Prognostic Factors of the Micropapillary Pattern in Patients Treated for Stage II and III Serous Borderline Tumors of the Ovary 
The Oncologist  2011;16(2):189-196.
In this study on 168 patients with stage II and stage III serous borderline tumor of the ovary, micropapillary pattern did not appear to signify a poor prognosis. The only prognostic factor for recurrence in these patients was the use of conservative surgery.
Learning Objectives
After completing this course, the reader will be able to: Discuss the prognostic impact of a micropapillary pattern in patients with stage II and III serous borderline ovarian tumors (SBOT).Consider when conservative surgery is an appropriate intervention in patients with SBOT-MP.
This article is available for continuing medical education credit at CME.TheOncologist.com
Background.
To determine the prognosis of a micropapillary (MP) pattern in patients with stage II and stage III serous borderline tumor of the ovary (SBOT).
Methods.
Review of patients with stage II and stage III SBOT treated or referred to our institution with characterization of an MP pattern and its clinical impact.
Results.
In 1969–2006, 168 patients were reviewed. Fifty-six patients had SBOT-MP. The rate of conservative surgery was lower in the SBOT-MP group than in the typical SBOT group, but the rate of patients with more than three peritoneal sites with implants was higher in the SBOT-MP group. The rate of invasive implants was not statistically different between the two groups. Eighteen recurrences were observed (six of them in the form of invasive disease) in the SBOT-MP group. Only one death was observed. The overall survival times and recurrence-free intervals were similar in both groups. The only prognostic factor for recurrence in the SBOT-MP group was the use of conservative surgery.
Conclusions.
In the present series, an MP pattern doesn't appear to signify a poor prognosis. The only prognostic factor for recurrence in SBOT-MP was the use of conservative surgery. Further studies on the MP pattern are needed to evaluate prognosis and the results of conservative surgery.
doi:10.1634/theoncologist.2009-0139
PMCID: PMC3228092  PMID: 21273510
Borderline tumor; Conservative surgery; Micropapillary pattern; Ovary; Peritoneal implants; Recurrence
6.  Prognostic Factors and Morbidities After Completion Surgery in Patients Undergoing Initial Chemoradiation Therapy for Locally Advanced Cervical Cancer 
The Oncologist  2010;15(4):405-415.
The study evaluates the prognostic factors and morbidities of patients undergoing completion surgery for locally advanced-stage cervical cancer after initial chemoradiation therapy.
Learning Objectives
After completing this course, the reader will be able to: Rate the prognostic factors for overall survival in patients undergoing completion surgery after initial chemoradiation therapy (CRT) for locally advanced cervical cancer.In cervical cancer patients undergoing completion surgery, consider using laparoscopy to decrease the morbidity of the surgery.In cervical cancer patients undergoing completion surgery, use PET-CT imaging to improve detection of para-aortic involvement.
This article is available for continuing medical education credit at CME.TheOncologist.com
Purpose.
The aim of this study was to evaluate the prognostic factors and morbidities of patients undergoing completion surgery for locally advanced-stage cervical cancer after initial chemoradiation therapy (CRT).
Patients and Methods.
Patients fulfilling the following inclusion criteria were studied: stage IB2–IVA cervical carcinoma, tumor initially confined to the pelvic cavity on conventional imaging, pelvic external radiation therapy with delivery of 45 Gy to the pelvic cavity and concomitant chemotherapy (cisplatin, 40 mg/m2 per week) followed by uterovaginal brachytherapy, and completion surgery after the end of radiation therapy including at least a hysterectomy.
Results.
One-hundred fifty patients treated in 1998–2007 fulfilled the inclusion criteria. Prognostic factors for overall survival in the multivariate analysis were the presence and level of nodal spread (positive pelvic nodes alone: hazard ratio [HR], 2.03; positive para-aortic nodes: HR, 5.46; p < .001) and the presence and size of residual disease (RD) in the cervix (p = .02). Thirty-seven (25%) patients had 55 postoperative complications. The risk for complications was higher with a radical hysterectomy (p = .04) and the presence of cervical RD (p = .01).
Conclusion.
In this series, the presence and size of RD and histologic nodal involvement were the strongest prognostic factors. Such results suggest that the survival of patients treated using CRT for locally advanced cervical cancer could potentially be enhanced by improving the rate of complete response in the irradiated area (cervix or pelvic nodes) and by initially detecting patients with para-aortic spread so that treatment could be adapted in such patients. The morbidity of completion surgery is high in this context.
doi:10.1634/theoncologist.2009-0295
PMCID: PMC3227965  PMID: 20332143
Chemoradiation therapy; Completion surgery; Locally advanced cervical cancer; Morbidities; Nodal involvement; Prognostic factors; Residual disease; Survival

Results 1-6 (6)