Ritesh Rathore

Brown University, Providence, Rhode Island, United States

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Publications (20)48.01 Total impact

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    ABSTRACT: OBJECTIVES:: To assess the effect on progression-free and overall survival from the addition of cetuximab to paclitaxel-based chemoradiation for patients with squamous cell head and neck cancer from Brown University Oncology Group studies. METHODS:: BrUOG HN-204 patients with stage III or IV locally advanced squamous cell cancer of the head and neck without distant organ metastases received 4 weeks of induction cetuximab followed by weekly cetuximab, paclitaxel, carboplatin, and concurrent radiation. Recurrence and survival data were compared with previous Brown University studies utilizing the same paclitaxel-based chemoradiation with and without induction chemotherapy. RESULTS:: The progression-free survival and overall survival at 3 years for all 37 patients initiating chemoradiation was 54% and 57%, respectively. All surviving patients were followed for at least 3 years and the median follow-up is 4.4 years. Of 14 patients who recurred within 3 years, 7 patients recurred locally only, 5 had a systemic recurrence, and 2 recurred both locally and systemically. CONCLUSIONS:: The addition of cetuximab to paclitaxel, carboplatin, and radiation achieves overall survival that is virtually identical to prior Brown University Oncology Group studies of paclitaxel-based chemoradiation without cetuximab. Improvements in locoregional control are needed despite the use of 3 agents to enhance the effects of radiation.
    American journal of clinical oncology 12/2012; · 2.21 Impact Factor
  • Source
    Ritesh Rathore
    03/2012; , ISBN: 978-953-51-0236-6
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    ABSTRACT: The long-term outcomes of selective organ preservation in operable, locally advanced head and neck cancers in two sequential chemoradiotherapy (CRT) protocols (HN-53, HN-67) are reported. A total of 65 patients were treated with CRT consisting of carboplatin (AUC=1/week) and paclitaxel (60 or 40 mg/m2/week) with radiation (1.8 Gy/day). After 5 weeks of CRT, if primary site biopsies were pathologically negative, then completion CRT to 67-72 Gy was done with neck dissection in node-positive cases. Alternatively, a positive rebiopsy required primary site resection and neck dissection followed by radiotherapy boost as deemed necessary. Pathologic complete responses occurred in 71% patients who then completed CRT; the remaining 29% patients underwent primary site surgery. The 5-year and median overall survival were 47% and 57 months with no statistically significant differences between the two groups. Overall long-term failure rates were: 6% local, 6% regional, and 32% distant. This strategy of selective organ preservation was effective in 71% patients with CRT, whereas salvage surgery was required in the remainder. Long-term survival was equivalent in both treatment groups.
    Annals of Surgical Oncology 05/2011; 18(12):3479-85. · 4.12 Impact Factor
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    ABSTRACT: To perform a phase II trial evaluating dose dense induction chemotherapy for locally advanced head and neck cancer. Thirty-five patients received 6 weekly doses of carboplatin (area under the curve=2) and paclitaxel (135 mg/m) followed by concurrent weekly paclitaxel (40 mg/m) and carboplatin (area under the curve=1) and daily radiation (66-72 Gy). There was 1 induction death from neutropenic sepsis and 1 sudden death during chemoradiotherapy. The overall response rate with induction was 79%. With >40 months of follow-up, the 36-month overall survival was 67% and squamous cell carcinoma of the head and neck survival 84%. Patients undergoing biopsy of the primary tumor site after the therapies had 17/18 (94%) pathologic complete response rate. The locoregional relapse rate was 40% (24 mo 28%) and distant relapse rate was 8% with only 1 distant site. Therapy was active but patients must be carefully selected and monitored. Compared with the historical controls, dose dense and intense induction chemotherapy decreased distant failure rate without compromising the locoregional control.
    American journal of clinical oncology 02/2011; 35(1):6-12. · 2.21 Impact Factor
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    ABSTRACT: A phase I study was performed to determine the maximally tolerated dose of carboplatin, ifosfamide, and docetaxel in advanced head and neck cancers. Carboplatin (week 1) was administered with weekly docetaxel and ifosfamide for 3 weeks in an every 4-week cycle. Restaging was done after two cycles, while dose level escalation was done in cohorts of three patients. Fifteen patients (recurrent/metastatic disease, n = 8; bulky locally advanced disease, n = 7) were enrolled. No dose-limiting toxicities were observed. Toxicities included grade 3 neutropenia and anemia (n = 2, each), and grade 2 thrombocytopenia (n = 3). The final level of carboplatin AUC = 6 (week 1) with docetaxel 30 mg/m(2) per week and ifosfamide 1,000 mg/m(2) per week was chosen for further evaluation. This novel regimen of carboplatin with weekly docetaxel and ifosfamide has a favorable toxicity profile and is active in this setting. Phase II study results are awaited.
    Cancer Chemotherapy and Pharmacology 11/2010; 66(6):1013-7. · 2.80 Impact Factor
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    ABSTRACT: To determine the feasibility and toxicity of the addition of cetuximab to paclitaxel, carboplatin, and concurrent radiation for patients with head and neck cancer. Patients with stage III or IV locally advanced squamous cell cancer of the head and neck, without distant organ metastases, were eligible. Patients received 4 weeks of induction cetuximab followed by weekly cetuximab, paclitaxel, carboplatin, and concurrent radiation. Thirty-two patients were assessable for chemoradiation toxicities. Grade 3 and grade 4 mucositis occurred in 53% and 16% of patients, respectively. Grade 3 and grade 4 radiation dermatitis occurred in 44% and 9% of patients, respectively. Grade 3/4 radiation dermatitis was associated with the use of intensity modulated radiation therapy (64% vs.14%, respectively, P < 0.0001). Grade 3 and grade 4 cetuximab associated acneiform rash developed in 6% and 3% of patients. Overall 21 patients (66%) had any grade 3 toxicity and 10 patients (31%) had any grade 4 toxicity. The percentages of the intended total dose delivered of carboplatin, cetuximab, paclitaxel, and radiation were 86%, 89%, 89%, and 96%, respectively. Cetuximab, when combined with paclitaxel, carboplatin and intensity modulated radiation therapy, increases dermatologic toxicity but does not increase mucosal toxicity as compared with previous Brown University Oncology Group studies of paclitaxel, carboplatin, and conventional radiation for patients with head and neck cancer.
    American journal of clinical oncology 09/2009; 33(2):144-7. · 2.21 Impact Factor
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    ABSTRACT: We performed a phase I study to evaluate the feasibility and determine the maximally tolerated dose of hepatic arterial infusion (HAI) of oxaliplatin in advanced hepatocellular carcinoma (HCC). Patients with unresectable or recurrent HCC received HAI-oxaliplatin over 2 hours at dose escalation levels of 90, 110, 130, and 150 mg/m given every 3 weeks. The therapy was continued until disease progression or excessive toxicity not amenable to appropriate modifications. Restaging was performed after every 2 cycles. A total of 23 patients were enrolled, with 17 patients evaluable for toxicity assessment. The median age was 63 years (range: 47-84 years), with 22 men and 1 woman. Stage distribution was as follows: stage II, 3 patients; stage III, 12 patients; and stage IV, 8 patients. A total of 53 cycles (range: 1-3) of HAI-oxaliplatin were delivered. The conventional grade 3/4 hematologic and gastrointestinal toxicities were infrequent. Among 17 evaluable patients receiving >2 cycles, 3 patients had partial responses and 8 had stable disease. A greater than 50% reduction in alphafetoprotein was seen in the 3 patients with partial responses and 3 patients with stable disease. HAI-oxaliplatin is a feasible, well tolerated, and demonstrated activity in this advanced HCC cohort. HAI-oxaliplatin 150 mg/m every 3 weeks was determined as the dose for further evaluation in phase II trials.
    American journal of clinical oncology 08/2009; 33(1):43-6. · 2.21 Impact Factor
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    ABSTRACT: Background.A phase II study was conducted using concurrent paclitaxel, carboplatin, and external beam radiotherapy (RT) in patients with advanced head and neck cancer.Methods.Forty-three patients (stage III, n = 12; stage IV, n = 31) were treated with 8 cycles of weekly paclitaxel (60 mg/m2), carboplatin (area under the curve [AUC] = 1), and RT (1.8 Gy daily; total dose, 66–72 Gy). Patients with initially palpable lymph nodes underwent neck dissection.Results.The overall clinical response rate was 91% (65% complete, 26% partial). Severe mucositis occurred in 37 (90%) patients, necessitating hospitalization in 13 (31%) patients. With a median follow-up of 49 months, the locoregional and distant failure rates were 26% and 21%, respectively.Conclusions.Concurrent paclitaxel, carboplatin, and RT for advanced head and neck cancer results in high complete response rates. Long-term follow-up has revealed the curative potential of this regimen, though the doses used resulted in unacceptable toxicity. © 2007 Wiley Periodicals, Inc. Head Neck 2008
    Head & Neck 02/2008; 30(3):289 - 296. · 2.83 Impact Factor
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    ABSTRACT: A phase I trial was conducted to determine the maximally tolerated dose (MTD) and dose-limiting toxicities (DLTs) of docetaxel, capecitabine, and carboplatin for first-line treatment of patients with metastatic esophageal and gastric cancers. Twenty-eight patients were treated over 5 dose levels in a 21-day cycle. Patients received carboplatin (AUC = 2) on days 1 and 8, docetaxel (35-40 mg/m2) on days 1 and 8, and capecitabine (500-2000 mg/m2) on days 1 to 10. There were no DLTs in the first cycle of treatment. Dose reductions were required in 10 of 15 patients at the final dose level due to neutropenia, nausea, vomiting, diarrhea, dehydration, and hand/foot syndrome following a median of 3 cycles of treatment. Therefore, escalation beyond dose level 5 was not attempted. The MTD was docetaxel, 40 mg/m2 days 1 and 8; carboplatin, AUC = 2 days 1 and 8; and capecitabine, 1500 to 2000 mg/m2 days 1 to 10 in a 21-day cycle. Ten of 25 patients who could be evaluated (40%) responded and 8 of 14 patients treated at the final dose level responded (57%). Cumulative gastrointestinal toxicities and neutropenia were the DLTs of docetaxel, capecitabine, and carboplatin. This combination represents an easily administered, active regimen for patients with metastatic gastric and esophageal cancers. Further evaluation of this regimen is indicated.
    American journal of clinical oncology 09/2005; 28(4):329-33. · 2.21 Impact Factor
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    ABSTRACT: Objectives: A phase I trial was conducted to determine the maximally tolerated dose (MTD) and dose-limiting toxicities (DLTs) of docetaxel, capecitabine, and carboplatin for first-line treatment of patients with metastatic esophageal and gastric cancers. Methods: Twenty-eight patients were treated over 5 dose levels in a 21-day cycle. Patients received carboplatin (AUC = 2) on days 1 and 8, docetaxel (35-40 mg/m2) on days 1 and 8, and capecitabine (500-2000 mg/m2) on days 1 to 10. Results: There were no DLTs in the first cycle of treatment. Dose reductions were required in 10 of 15 patients at the final dose level due to neutropenia, nausea, vomiting, diarrhea, dehydration, and hand/foot syndrome following a median of 3 cycles of treatment. Therefore, escalation beyond dose level 5 was not attempted. The MTD was docetaxel, 40 mg/m2 days 1 and 8; carboplatin, AUC = 2 days 1 and 8; and capecitabine, 1500 to 2000 mg/m2 days 1 to 10 in a 21-day cycle. Ten of 25 patients who could be evaluated (40%) responded and 8 of 14 patients treated at the final dose level responded (57%). Conclusions: Cumulative gastrointestinal toxicities and neutropenia were the DLTs of docetaxel, capecitabine, and carboplatin. This combination represents an easily administered, active regimen for patients with metastatic gastric and esophageal cancers. Further evaluation of this regimen is indicated.
    American Journal of Clinical Oncology 07/2005; 28(4):329-333. · 2.55 Impact Factor
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    ABSTRACT: To conduct a phase I study incorporating trastuzumab with paclitaxel, cisplatin, and radiation for adenocarcinoma of the esophagus. Patients with adenocarcinoma of the esophagus without distant organ metastases were eligible. All patients received cisplatin 25 mg/m2 and paclitaxel 50 mg/m2 weekly for 6 weeks with radiation 50.4 Gy. HER-2/neu-positive patients (2+/3+ by immunohistochemistry) received weekly trastuzumab at dose levels of 1, 1.5, or 2 mg/kg weekly for 5 weeks after an initial bolus of 2, 3, or 4 mg/kg, respectively. HER-2/neu-negative patients received the same chemoradiation without trastuzumab as a control for toxicity. Dose-limiting toxicities were defined as grade 3 esophageal, cardiac, or pulmonary toxicity. Twelve of 36 screened patients (33%) overexpressed HER-2/neu by immunohistochemistry (seven 3+ and five 2+). Eight of 12 patients with HER-2/neu overexpression by IHC had an increase in the number of HER-2/neu genes, six from amplification of the HER-2/ neu gene and two were hypderdiploid for chromosome 17. Thirty patients were enrolled (12 HER-2/neu-positive and 18 HER-2/neu-negative controls). No increase in toxicity was seen with the addition of trastuzumab. One of 12 patients in the trastuzumab arm and 8 of 17 in the control arm had grade 3 esophagitis (p < or = .026). Mean left ventricular ejection fraction for the trastuzumab group was 57% before treatment and 56% after treatment. HER-2/neu is overexpressed in approximately one-third of esophageal adenocarcinomas. Trastuzumab can be added at full dose to cisplatin, paclitaxel, and radiation. Future studies of trastuzumab in esophageal adenocarcinoma are indicated.
    Cancer Investigation 02/2004; 22(5):670-7. · 2.24 Impact Factor
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    ABSTRACT: To determine the response rate and toxicities of Herceptin and gemcitabine for patients with metastatic pancreatic adenocarcinomas that overexpress HER-2/neu. Patients with metastatic pancreatic cancer with 2+/3 + HER-2/neu expression by immunohistochemistry were eligible. Patients received gemcitabine, 1 g/m2/week, for 7 of 8 weeks followed by 3 of every 4 weeks, and Herceptin, 4 mg/kg loading dose, followed by 2 mg/kg/week. Screening logs demonstrated the rate of HER-2/neu overexpression was 16%. Thirty-four patients were enrolled. Thirty patients (88%) had pancreatic cancers with 2+ overexpression and 4 patients (12%) had 3+ overexpression. Toxicity was similar to gemcitabine alone. Confirmed partial responses were observed in 2 of 32 patients (6%). Thirteen of 32 patients (41%) had either a partial response or a >50% reduction in CA 19-9. The median survival for all 34 patients was 7 months, and the 1-year survival was 19%. The response rate of Herceptin and gemcitabine is similar to gemcitabine alone. The 7-month median survival in patients with metastatic pancreatic cancer suggests there may be a modest benefit for some patients. Infrequent HER-2/neu overexpression limits the role of targeting the HER-2/neu gene and prevents definitive conclusions on the addition of Herceptin to gemcibine for patients with pancreatic cancer.
    Cancer Investigation 02/2004; 22(5):706-12. · 2.24 Impact Factor
  • Cancer Investigation - CANCER INVEST. 01/2004; 22(5):706-712.
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    ABSTRACT: We conducted a Phase I study of weekly paclitaxel (P) and carboplatin (C) in patients with advanced malignancies to determine the maximum tolerated dose (MTD) of this combination. Dose levels were escalated independently for patients with and without previous chemotherapy exposure and advanced malignancies. Both agents were administered weekly for 6 weeks followed by a 2-week break per cycle. P, escalated to tolerance starting at 135 mg/m(2) per week, and C, fixed dose at area under the curve (AUC) = 2 mg/mL/min, were administered to groups of three or six patients. Doses were modified for granulocyte counts less than 1800/microL or for neurotoxicity greater than Grade 1. MTD was defined as the highest dose level at which less than 50% of patients developed unacceptable toxicity and received more than 80% of the intended dose during the first cycle. Dose levels were escalated until these conditions were exceeded. Twenty-seven patients (12 patients with previous chemotherapy exposure and 15 chemotherapy-naive patients) were examined for toxicity. Dose escalation was halted due to neutropenia and/or Grade 2/3 neuropathy in both arms. The MTD was P = 135/C = 2 for patients with previous chemotherapy exposure and P = 150/C = 2 for chemotherapy-naive patients. The combination of P and C administered on a weekly schedule permits a two to threefold enhancement of P dose intensity with full doses of C. Phase II trials of this regimen in patients with various malignancies are being evaluated to determine efficacy and tolerance.
    Cancer 12/2002; 95(9):2000-5. · 5.20 Impact Factor
  • Howard Safran, Ritesh Rathore
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    ABSTRACT: Paclitaxel and concurrent radiation (paclitaxel/RT) have been evaluated by the Brown University Oncology Group (BrUOG) and the Radiation Therapy Oncology Group (RTOG) in phase I and II studies for patients with locally advanced pancreatic cancer. The dose limiting toxicities were abdominal pain within the radiation field, nausea and anorexia. The phase II Brown University study, utilizing paclitaxel 50 mg/m(2) per week for 6 weeks with 50.4 Gy radiation, demonstrated modest locoregional activity and acceptable toxicity. The median and 1-year survival of paclitaxel/RT in the RTOG phase II study suggests an improvement over previous RTOG studies of fluorouracil (5-FU) and radiation. The addition of gemcitabine to paclitaxel and radiation has also demonstrated promising preliminary activity and a phase II study by the RTOG is being initiated.
    Critical Reviews in Oncology/Hematology 08/2002; 43(1):57-62. · 4.64 Impact Factor
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    ABSTRACT: Novel systemic treatments are needed in pancreatic cancer. The authors sought to establish the frequency of overexpression of the HER-2/neu oncogene in patients with pancreatic adenocarcinoma to determine the potential role of trastuzumab (Herceptin) as a therapeutic agent in this disease. Tumor specimens from patients with pancreatic adenocarcinoma were analyzed by staining for p185HER2 protein using the DAKO immunohistochemical assay. Patients with and without HER-2/neu overexpression by immunohistochemistry were compared with respect to clinical and pathologic characteristics. HER-2/neu gene amplification was also evaluated by fluorescence in situ hybridization (FISH). Thirty-two of 154 patients (21%) had pancreatic adenocarcinoma that demonstrated HER-2/neu overexpression by immunohistochemistry. At initial diagnosis, 16% of resectable cancers, 17% of locally advanced cancers, and 26% of metastatic cancers were determined to have HER-2/neu overexpression. Three of 11 (27%) patients with HER-2/neu overexpression by immunohistochemistry had gene amplification by FISH. HER-2/neu overexpression occurs in a subset of pancreatic cancer. Evaluation of the efficacy of trastuzumab for patients with pancreatic cancer who overexpress HER-2/neu appears indicated.
    American Journal of Clinical Oncology 11/2001; 24(5):496-9. · 2.55 Impact Factor
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    ABSTRACT: To determine the activity and toxicity of paclitaxel and concurrent radiation for pancreatic cancer. Forty-four patients with locally unresectable pancreatic cancer were studied. Patients received paclitaxel, 50 mg/m(2) by 3 h i.v. (IV) infusion, weekly, on Days 1, 8, 15, 22 and 29. Radiation was administered concurrently to a total dose of 50.4 Gy, in 1.80 Gy fractions, for 28 treatments. Nausea and vomiting were the most common toxicities, Grade 3 in five patients (12%). Two patients (5%) had Grade 4 hypersensitivity reactions to their first dose of paclitaxel. Of 42 evaluable patients, the overall response rate was 26%. The median survival was 8 months, and the 1-year survival was 30%. Concurrent paclitaxel and radiation demonstrate local-regional activity in pancreatic cancer. Future investigations combining paclitaxel with other local-regional and systemic treatments are warranted.
    International Journal of Radiation OncologyBiologyPhysics 05/2001; 49(5):1275-9. · 4.52 Impact Factor
  • European Journal of Cancer - EUR J CANCER. 01/2001; 37.
  • European Journal of Cancer - EUR J CANCER. 01/2001; 37.
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    ABSTRACT: Pancreatic adenocarcinomas are among the most resistant neoplasms to conventional chemotherapeutics. This has prompted intense investigations of novel non-cytotoxic agents based on new understandings of the molecular pathobiology of human malignancies. This review will focus on the potential uses of three new classes of agents: farnesyl transferase (FTPase) inhibitors, matrix metalloproteinase inhibitors (MMPI's) and antibodies to the HER-2/neu oncogene. When used as single agents, FTPase inhibitors and MMPI's may be cytostatic, helping to delay the growth of these cancers. All three classes of agents may have the greatest benefit when used in conjunction with traditional anticancer modalities. The biology of these agents will reviewed.
    Frontiers in Bioscience 12/1998; 3:E226-9. · 3.29 Impact Factor

Publication Stats

331 Citations
48.01 Total Impact Points

Institutions

  • 2002–2012
    • Brown University
      • Department of Medicine
      Providence, Rhode Island, United States
    • Rhode Island Hospital
      Providence, Rhode Island, United States
    • University of Utah
      • School of Medicine
      Salt Lake City, UT, United States
  • 2011
    • Landmark Medical Center
      Woonsocket, Rhode Island, United States
  • 2009–2011
    • Roger Williams University
      Bristol, Rhode Island, United States