Ritu Salani

The Ohio State University, Columbus, Ohio, United States

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Publications (3)11.79 Total impact

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    ABSTRACT: To determine the maximum tolerated dose (MTD) and acute dose-limiting toxicities (DLT) of intravenous topotecan administered with weekly cisplatin during pelvic radiation therapy in patients with locally advanced cervical cancer. Patients were treated at one of two dose levels receiving intravenous topotecan at 0.5mg/m(2) and cisplatin at either 30 or 40 mg/m(2) given weekly for 6 weeks concurrently with pelvic radiation and intracavitary brachytherapy. The primary endpoint for the escalation study was acute dose-limiting toxicities occurring within 30 days of completing radiation therapy. Eleven patients were enrolled. Dose-limiting toxicity consisting of Grade 3 nausea and vomiting lasting >24h in one patient and grade 3 febrile neutropenia in another patient occurred at the first dose level of weekly topotecan 0.5mg/m(2) and cisplatin 40 mg/m(2). This necessitated de-escalation to weekly cisplatin 30 mg/m(2) in combination with topotecan 0.5mg/m(2) and pelvic radiation. This dose level was tolerable in 6 evaluable patients with only one DLT consisting of grade 4 thrombocytopenia, grade 3 abdominal pain and grade 3 elevated gamma glutamyl transpeptidase (GGT). In women with locally advanced cervical cancer, intravenous topotecan 0.5mg/m(2) and cisplatin 30 mg/m(2) given weekly for 6 weeks with concurrent pelvic radiation and intracavitary brachytherapy were tolerable. Further expansion of the feasibility cohort of this study was suspended based on the results of a phase 3 trial comparing the efficacy of platinum combinations in advanced and recurrent cervical cancer.
    Gynecologic Oncology 12/2011; 125(1):158-62. · 3.93 Impact Factor
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    ABSTRACT: In GOG 184, the addition of paclitaxel to cisplatin and doxorubicin offered no additional clinical benefit, yet was associated with increased provider-rated toxicity. We now compare patient-reported neuropathy between treatment arms and patient reports to the clinician reports of neuropathy. Of 659 enrolled patients, 552 were randomly assigned to receive either cisplatin 50 mg/m² + doxorubicin 45 mg/m²+G-CSF 5 μg/kg on days 2-11 ("CD"), or the above regimen plus paclitaxel 160 mg/m² infused over 3h ("CDP"). Patient-reported neuropathy was measured with 11-item Functional Assessment of Cancer Therapy - Neurotoxicity (FACT-Ntx) Scale, at baseline, and 4 weeks and 6 months post chemotherapy. Group differences on patient-reported neuropathy over time, and correspondence between patient and provider ratings, were evaluated by fitting linear mixed models to the data. After adjusting for non-significant baseline differences in neuropathy, the average neuropathy (FACT-Ntx) score of CDP-treated patients was 5.2 points lower/worse (95% CI: 4.0-6.5; p < 0.001) than the average score observed in CD-treated patients. The difference diminished after 6 months but still remained statistically significant (difference = 1.6; 95% CI: 0.3-2.8; p = 0.014). The sensory component was most significantly affected. Each increase (worsening) of grade in provider-rated toxicity was significantly associated with change in patient-reported severity of 4-6 points in the 11-item total score and 2-3 points in the 4-item sensory neuropathy score. Patient-reported neuropathy was worse in CDP-treated patients compared to CD-treated patients, especially in the sensory component. Patient-reported change corresponded with provider grade, but offered more detail on the nature of impact.
    Gynecologic Oncology 12/2010; 119(3):538-42. · 3.93 Impact Factor
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    ABSTRACT: We sought to determine if patient age influenced chemotherapy completion rate, complication rate, or progression free survival (PFS) among patients who received intraperitoneal (IP) chemotherapy for epithelial ovarian, fallopian tube, or primary peritoneal cancers. Charts for patients receiving IP chemotherapy between January 2006 and September 2009 were reviewed at three institutions. Primary outcomes included completion rate of planned IP chemotherapy, complication rate, and PFS. Completion rates were categorized as 0-49%, 50-99%, or 100% of planned treatments were delivered. The tolerability of IP versus intravenous (IV) chemotherapy was also compared among patients ≥ 70 years. One hundred nine patients receiving IP chemotherapy were identified, 86 were < 70 years and 23 were ≥ 70 years. All patients received IP cisplatin and paclitaxel in combination with IV paclitaxel or docetaxel. Patients ≥ 70 years old were less likely to complete all planned cycles of IP chemotherapy than the younger cohort (OR = 0.33, 95% CI 0.13-0.83, p = 0.01), but there was no significant association between age and complication rate or PFS (p = 0.82 and p = 0.68, respectively). Optimally debulked patients ≥ 70 years receiving IV chemotherapy completed more cycles than patients ≥ 70 receiving IP chemotherapy (p < 0.01). Although elderly patients appear to tolerate fewer cycles of IP chemotherapy, they do not have higher objective complication rates or impaired PFS compared to younger patients. Age alone should not limit access to IP chemotherapy.
    Gynecologic Oncology 09/2010; 119(3):491-5. · 3.93 Impact Factor