tbuckley/cabot-search huggingface dataset:
Comparison of paclitaxel and carboplatin with ifosfamide and cisplatin for the treatment of ovarian carcinosarcoma
Authors: M. R. Santacruz, P. A. Gehrig, E. N. Skinner, J. F. Boggess, W. C. Fowler, L. Van Le
Journal: Journal of Clinical Oncology (2004)

5116 Background: Ovarian carcinosarcoma is associated with a poor prognosis. There has been increasing controversy over the appropriate and most efficacious postoperative therapy in women with this disease. We reviewed and evaluated the disease-free interval and overall survival of women with ovarian carcinosarcoma based on the post-operative chemotherapy they received. Methods: A retrospective analysis was performed on women with ovarian carcinosarcoma treated at our institution between 1981 and 2002. Operative procedures, post-operative therapy, treatment related toxicities, disease-free interval, and overall survival data were recorded. The two treatment regimens were paclitaxel (175 mg/m2) with carboplatin (AUC 5) administered every four weeks or ifosfamide (1.5 g/m2) with cisplatin (20mg/m2) for days one through four, every three weeks. An unpaired t test was performed to compare disease-free interval, overall survival, and toxicity for the two treatment groups. Results: Eleven women received primary therapy with one of the two regimens. The disease-free interval for the women who received paclitaxel and carboplatin (n=7) was 23.4 months (range 6–42+) as compared to 27.3 months (range 5–54+) in those receiving ifosfamide and cisplatin (n=4) (p=0.7622). Median overall survival was 35.4 months (range 4–87+) versus 37 months (range 21–54+), respectively (p=0.8922). Three ifosfamide/cisplatin recipients presented with febrile neutropenia. Two required packed red cell transfusion for anemia and one required a platelet transfusion for thrombocytopenia. In addition, one suffered acute renal failure. In the paclitaxel/carboplatin group, one had an episode of febrile neutropenia. Five had no chemotherapy related toxicity, and one expired from an unknown etiology. Conclusions: Paclitaxel and carboplatin appears to be as effective as ifosfamide and cisplatin in the treatment of ovarian carcinosarcoma. We would advocate that women with ovarian carcinosarcoma receive post-operative therapy with a paclitaxel/platinum-based regimen as outcomes were similar and there is less toxicity and improved patient convenience. No significant financial relationships to disclose.
Phase II study on pemetrexed in advanced and/or recurrent cervical cancer patients: a MITO study
Authors: G. Ferrandina, D. Lorusso, M. Ludovisi, S. Pignata, R. Sorio, G. Mangili, E. Breda, F. Legge, S. Pisconti, G. Scambia
Journal: Journal of Clinical Oncology (2008)

5515 Background: The objective of the study was to evaluate the activity of the new-generation multitarget antifolate drug, pemetrexed, in a population of advanced and/or recurrent cervical cancer patients. Methods: Patients with advanced and/or recurrent cervical cancer which failed a previous treatment with platinum-based chemotherapy and/or radiotherapy, not amenable for surgery and/or radiotherapy, with evidence of measurable disease in a not previously irradiated field, were treated with pemetrexed 500 mg/mq administered as a 10-min infusion on day 1 of a 21-day cycle. Patients received a supplementation with folic acid and vitamin B12. The evaluation of response rate was the primary endpoint of the study. This is a two stage phase II trial according to Simon design. Assuming that pemetrexed may obtain a 25% response rate, the study have enrolled initially 18 patients; in case of > 3 objective responses, the accrual will continue until the total number of 43 patients is reached (α=0.05; β=0.80). Results: 18 patients (median age: 62 yrs, range 30–77; ECOG performance status 0/1/2 of 3/10/5) were enrolled: 3 partial responses (16.7%) and 10 (55.6%) stabilization of disease were registered. The median response duration was 7 months (range 7–27) and the median stabilization of disease was 17.5 months (range 10–37). Overall, 72 cycles were administered with a median value of 3 (range 1–9) cycles/patient. Major toxicities were as follows: G4 thrombocytopenia occurred in 1(1.4%) cycles; G4 and G3 neutropenia in 4(5.5%) and 8 (11.1%) cycles, respectively; G3 anemia in 12 (16.7%) cycles; G4 and G3 fatigue in 1(1.4%) and 3(4.1%) cycles, respectively; G4 and G3 diarrhea in 1(1.4%) and 2(2.8%) cycles, respectively; G3 liver toxicity in 3(4.1%) cycles. Skin rash was observed in 4 patients (22.2%), all recovered with a short period of antihistaminic plus corticosteroid treatment. Two patients abandoned the study because of persistent G2 increase of creatinine serum levels. Conclusions: Pemetrexed treatment showed encouraging activity in the treatment of advanced or recurrent cervical cancer. The second step is warranted. No significant financial relationships to disclose.
Feasibility and effectiveness of inhaled carboplatin in the treatment of NSCLC patients.
Authors: P. Zarogoulidis, E. Eleftheriadou, V. Zarogoulidou, I. Sapardanis, T. Kontakiotis, L. Sichletidis, K. Zarogoulidis
Journal: Journal of Clinical Oncology (2010)

e17511 Background: Inhaled chemotherapy is still under investigation as an alternative therapeutic modality for NSCLC treatment regarding to respiratory function side effects. Methods: In this study 42 NSCLC patients divided in 3 groups were included. In 10/42 patients (group A - control group): IV chemotherapy was administrated (carboplatine AUC ≈ 6 D1); in 24/42 (group B - partial inhaled carboplatine): 2/3 of carboplatine IV predicted dose was IV administered and the rest 1/3 was administered as aerosol (jet rebulized D1); in 8/42 (group C - totally inhaled chemotherapy): all the predicted IV dose was administered as aerosol in 3 equally divided fractions D1-3. In all patients IV docitaxel 100/m2 was as well administered (D1). Inhaled carboplatine was administered via jet mebuliser (Medic - Aid Up mist) operated at 8-10 L O2min-1 in order to obtain droplets of less than 3 μ m diameter. Lung functional Tests (Lfts) were performed in all groups before and after chemotherapy in third and sixth cycle. Results: Group B had a statistically significant increase in survival compared to control group 266 days (95% CI 250-281) vs. 187 (95% CI 148-225). Moreover a 63 days survival benefit was observed in group C patients compared to control group but this was not statistically significant. Regarding to LFTs a statistically significant decline was observed only in FEV1 in group C patients in 6 months compared to the initial measurement. Finally lung HRCT was not changed in any patient group except in group C where a temporary acute inflammatory transient pattern was observed. Conclusions: From this ongoing study it is likely that patients in partial inhaled chemotherapy have a statistically significant survival benefit without any side effect in respiratory function. No significant financial relationships to disclose.
Healers, providers of complementary/ alternative medicine, may be dangerous to all oncological patients including themselves
Authors: P. Lemez, J. Stejskal, S. Cahova, V. Benesova, D. Dvorakova, J. Fisar, L. Slavicek
Journal: Journal of Clinical Oncology (2004)

6137 Background: It is well known that healers may be dangerous to patients with malignant oncological diseases. We had the possibility to examine, treat and follow-up 3 locally well-known healers from 3 towns of the Czech-Moravian Highland at our hospital in 1999–2000. Methods: Healers used for their clients following healing practices: the sensual establishing causes (”diagnosis“) of client's health problems, removal of a bad energy or pain with hands cleaned in water, providing positive energy, treatment with herbal mixtures and teas, homeopathy, etc. Currently used medical therapy was offered to all of them. Results: All three healers were females, aged 57–64 years at diagnosis who came with very advanced tumors after the 6–36 months of symptoms duration in which two had tried to cure themselves. The 64 year-old woman with breast cancer T4b N2 M1 (SKI, LYM) survived 13 months after radiotherapy plus tamoxifen. The 57 year-old female with breast cancer T4b N2 M0 and 60 year-old one with eosophageal cancer T4 N1 M1 (HEP) refused radiotherapy after the 5th (as well as FAC chemotherapy) and 10th fraction, respectively, and died within 3–4 months since diagnosis. Conclusions: 1. Healers did not diagnose their illness in spite of the long-term presence of sings and symptoms. 2. They came with the 6–36 months' delay to medical examination and thus their tumours were very advanced. at medical diagnosis. 3. They were not able to improve their health status with their own healing practices. 4. Two healers interrupted usual medical therapy shortly after its beginning and their survival was only 3–4 months since diagnosis while the third survived 13 months with this therapy. 5. All three began their healing practice after an experience in being a patient for 2 months to years for a serious illness. 6. They claimed that their main goal had been
The prospective estimation of blood serum free IGF-1, insulin concentration, and body mass index as a prognostic factor for breast cancer patients.
Authors: Elzbieta Nowara, Joanna Huszno, Katarzyna Drosik-Rutowicz, Ewa Nowara, Barbara Maslyk
Journal: Journal of Clinical Oncology (2013)

47 Background: Numerous epidemiologic findings suggest that an increase in IGF-1, insulin concentration and body mass index correlates with the risk of developing certain types of malignant tumors, including breast cancer. They may also have an influence on the cancer stage. The purpose of this study was to prospectively evaluate the correlation of body mass index (BMI), insulin, and free IGF-1 concentration with cancer stage. Methods: Prospective analysis has been conducted in 2011 in Cancer Center and Institute of Oncology in Gliwice, Poland. This study has been approved by Bioethics Committee according to national regulations. The pilot group included 138 patients with breast cancer treated with chemotherapy, 76% in adjuvant setting and 24% due to cancer dissemination. Results: Patients’ median weight was 70kg (range 52-106kg) and median BMI was 27 (range 18.8-40.8). Patients with HER2 overexpression had diabetes more frequently (8% vs. 0%), p=0.06. Patients with higher BMI more frequently had negative steroid receptor status (42% vs. 25%) p=0.06, and significantly more often were in postmenopausal period (81% vs. 52%), p=0.00029. Tumor stage was significantly more advanced in patients with lower physical activity, p=0.04. Tumor stage was insignificantly more advanced in patients with higher plasma insulin level, p=0.09. Multivariate analysis had shown that overweight patients with more advanced stage of breast cancer had negative steroid receptors more often, p=0.033. Patients with metastatic breast cancer often had higher insulin plasma levels in comparison to patients with early breast cancer (7% vs. 1%), p=0.09. The multivariate analysis also showed that patients with diabetes had more frequently more often overexpression of HER2 and were in a more advanced cancer stage, p=0.03. Conclusions: Hyperinsulinemia may be a risk factor for more advanced stage of disease. There is a possibility that the effect of being overweight on breast cancer stage is mediated by estrogen metabolism. This analysis is scheduled to be performed later in the project.
Change in symptom burden within one day of palliative care consultation in a cohort of gynecologic oncology inpatients.
Authors: Carolyn Lefkowits, Winifred Teuteberg, Madeleine Courtney-Brooks, Paniti Sukumvanich, Joseph L. Kelley
Journal: Journal of Clinical Oncology (2014)

28 Background: Change in symptom burden after inpatient palliative care consultation for symptom management in gynecologic oncology patients has not been described. Our objective was to evaluate the magnitude and time course of change in symptom burden after palliative care (PC) consultation in a cohort of gynecologic oncology inpatients. Methods: Women with a gynecologic malignancy and a PC consultation for symptom management between 3/1/12 and 2/28/13 were identified. Charts were reviewed for demographics and disease characteristics. PC provider reports of patient symptom intensity on a modified Edmonton Symptom Assessment System were retrospectively reviewed. Data was analyzed with descriptive statistics and two sample test of proportions to compare prevalence of moderate to severe symptom intensity on the day of consultation to the day after consultation. Results: Over 12 months, there were 172 PC consultations for symptom management involving 123 unique patients. The median age was 58 and most common cancer was ovarian (44%), followed by cervical (26%) and uterine (24%). Prevalence of moderate to severe symptoms on the day of consultation is outlined below. There were statistically significant decreases in prevalence of moderate to severe symptom intensity within one day of PC consultation for pain, anorexia, fatigue and shortness of breath (SOB) (see table). Conclusions: PC consultation is associated with significant improvements in symptoms within one day of consultation. Palliative care consultation may be an effective tool for symptom management during even very short hospitalizations and should be considered early in the hospitalization to effect timely symptom relief. [Table: see text]
PEGINTERFERON ALFA-2A (40KD) (PEGIFN alpha 2A) HAS A WIDE SAFETY MARGIN IN COMBINATION WITH RIBAVIRIN (RBV) 1000/1200 MG/DAY IN PATIENTS INFECTED WITH HCV GENOTYPE 1: POOLED ANALYSIS OF DATA FROM FOUR RANDOMIZED MULTICENTER STUDIES
Authors: P Marcellin, DM Jensen, SK Roberts, SJ Hadziyannis, GJ Dore, M Diago, M Weltman, GW McCaughan, W Cheng, DH Crawford, W Sievert, W Rawlinson, J Solsky, A Tietz, M Rizzetto
Journal: Hepatology (2009)
Feasibility of bevacizumab (NSC 704865, BB-IND# 7921) combined with vincristine, topotecan, and cyclophosphamide in patients with first recurrent Ewing sarcoma (EWS): A Children's Oncology Group (COG) study.
Authors: P. Leavey, J. L. Glade Bender, L. Mascarenhas, L. Granowetter, M. Anderson, M. D. Krailo, R. G. Gorlick, N. Marina
Journal: Journal of Clinical Oncology (2010)

9552 Background: The importance of angiogenesis in EWS has been well explored and activity of angiogenesis inhibitors observed in relevant pre-clinical models. The combination of topotecan and cyclophosphamide has a 36% response rate in patients with recurrent EWS. Consequently COG AEWS0521 was designed to prospectively study the feasibility of combined administration of bevacizumab with vincristine, topotecan, and cyclophosphamide. Methods: EWS patients with first recurrence were eligible. Patients received intravenous bevacizumab 15mg/kg (Day 1), vincristine 1.5 mg/m2 (Days 1, 8 and 15), topotecan 0.75 mg/m2 (Days 1-5) and cyclophosphamide 250 mg/m2 (Days 1-5) of each 21-day cycle. DLT was defined as Gr4 hematological toxicity lasting > 7 days with myelosuppression causing therapy delay > 14 days, >Gr3 thromboembolic events, >Gr3 bleeding events, > Gr2 hypertension, and > Gr2 proteinuria. Feasibility analysis was performed after the first two cycles. In the absence of progressive disease patients received up to 12 cycles (4 blocks) of therapy. Results: Seven patients were enrolled, 6 of whom were fully evaluable for feasibility. The in-evaluable patient received < 85% of the planned bevacizumab dose during the first cycle due to administration error. Overall 23 blocks of therapy were administered, with expected toxicities of Gr4 platelets (52%), Gr4 neutrophils (48%), uncomplicated febrile neutropenia (22%) and infection with neutropenia (22%). One patient experienced Gr3 esophageal stricture having received radiation for a primary chest wall Ewing and proton beam radiation during relapsed therapy. No patients experienced DLT. Two patients developed progressive disease after 1 and 2 therapy blocks. Five patients completed all 4 therapy blocks with either complete response or stable disease. Conclusions: The combination of bevacizumab with vincristine, topotecan, and cyclophosphamide is feasible in patients with first recurrent EWS and warrants ongoing study to determine clinical efficacy. No significant financial relationships to disclose.
A phase II multicenter study of the cell cycle inhibitor indisulam in refractory metastatic breast carcinoma
Authors: R. Oratz, J. Blum, K. Rowland, C. Cunningham, S. Jacobs, J. Arseneau, D. Richards, F. G. Renshaw, F. Holmes, J. O’Shaughnessy
Journal: Journal of Clinical Oncology (2005)

685 Background: Indisulam (E7070) is a sulfonamide that inhibits cell cycle progression at multiple checkpoints by inducing expression of p53, p21 and suppressing expression of phosphorylated Rb, cyclins, and cyclin-dependent kinases. An exploratory, study in refractory breast cancer revealed a 15% response rate, with 40% stable disease. We therefore conducted an open-label, Phase II study of indisulam in metastatic breast cancer refractory to standard therapy.Methods: The primary endpoint is response rate, to be independently evaluated via RECIST criteria after accrual of 42 and 110 patients (pts). Secondary endpoints include progression free survival (PFS), time to progression (TTP), median/six month survival, Quality of Life (QOL), using FACT-B analysis, and safety. Eligibility criteria: KPS ≥ 70%. Patients were required to have prior chemotherapy with an anthracycline, taxane and fluoropyrimidine. Any number of prior regimens was permitted. Pts initially received indisulam 800 mg/m2 every 3 weeks. However dose-limiting toxicity observed in the first 3/7 patients led to dose reduction to 700 mg/m2.Results: To date, 49 pts have been enrolled. Results thus far are based on data from 26 pts who have received a total of 1 cycle, 11 pts who have received 2–3 cycles and 2 pts who have received 4–6 cycles. Of 15 pts evaluable for response, 6 have had a best response of stable disease (5 ongoing), 6 pts discontinued with disease progression, and 3 with toxicity. Attributable CTC Grade 3 or 4 adverse events were reported in a total of 6 patients with 8 events. These included neutropenia (3), thrombocytopenia (2), febrile neutropenic sepsis, with hypotension (1), hyperbilirubinemia with encephalopathy (1), sulfonamide allergy (1), and death (1). Analysis of response rates, PFS, TTP, QOL, and six-month survival is ongoing.Conclusions: Indisulam toxicity is acceptable. Efficacy analysis is continuing. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eisai Medical Research Eisai Medical Research
VICTOR: Vinflunine (Vin) in advanced metastatic transitional cell carcinoma of the urothelium (TCCU)—A retrospective analysis of use of Vin in multicenter, real life setting as second-line chemotherapy (ChT) through free-of charge-programme (FOCP) for patients (pts) in the UK.
Authors: Syed A. Hussain, Jawaher Ansari, Robert Anthony Huddart, James Wylie, Maria Vilarino-Varela, Guy Faust, Melissa Tan, Jeanette Lyons, Alison Hassall, Carlos Escriu, Seema Chauhan, Richard Jackson
Journal: Journal of Clinical Oncology (2015)

352 Background: There is no standard of care currently in UK for second line ChT for pts with advanced TCC. Vin is approved for TCCU for pts who have failed a platinum-based regimen and is now the standard ChT in 2nd line in Europe based on large phase III randomised trial data showing 2.6 months survival advantage. ESMO guidelines recommended it as the only option for pts in the 2nd line setting. Vin is not currently available in NHS practice in UK as it is not on the approved list of drugs on cancer drug fund. Methods: Data are collected retrospectively on pts who received Vin as a 2nd line treatment through FOCP. The dose of Vin was 240-320 mg/m2 every 3 weeks. The aim was to document the toxicity, radiological RR and OS for pts treated with Vin in real life setting within the FOCP. Results: At the time of analysis data from 37 pts from 6 sites were available. Median pts age was 64 years(range: 57-69), 24m; 13 f. All pts had advanced metastatic TCC. 9 pts had bone or liver mets, 3 pts had PS 2 and 5 pts had HB &lt;10, all known poor prognostic indicators in palliative ChT setting. Total of 179 cycles have been delivered (median 3 ; mean 5; range1-16). Grade 3 / 4 toxicity: Anaemia 2/179, Neutropenia 2/179, Neutropenic infection 2/179, Constipation 4/179, Fatigue 3/179. Grade 2 toxicity; Anaemia 5/179, Neutropenia 13/179, Thrombocytopenia 2/179, Febrile infection 1/179, Constipation 9/179, Fatigue 20/179, Abdominal pain 2/179, Vomiting 8/179. 30 pts were evaluable for response. 11 pts had PR, 6 had SD, 13 had PD and 7 were not evaluable. Partial RR was 30 % with ITT and 37% for evaluable pts. Median OS was 9.5 (95% CI; 5.9- 16.9) months. Conclusions: Real life data showing a median OS of 9.5 m by ITT for all pts are encouraging and consistent with real life data from Europe (Spanish, German and French) presented at ESMO 2013. Toxicity has further improved with the use of prophylactic laxatives and oral antibiotics.
Phase III study evaluating the role of docetaxel in the adjuvant setting of breast cancer patients with ≥ 4 involved lymph nodes: ADEBAR-Study
Authors: K. Gauger, F. V. Bismarck, M. Heinrigs, W. Janni, D. Steinfeld, D. Augustin, H. Sommer, K. Friese, M. Kiechle, N. Harbeck
Journal: Journal of Clinical Oncology (2005)

908 Background: The current data of the BCIRG 001-study support the probable advantage of the taxanes in the adjuvant therapy of primary breast cancer. Nevertheless, the indication for breast cancer patients with more than 3 involved lymph nodes, as well as the optimal scheduling still remains unclear. Aim of this ongoing study is to compare toxicity and survival rates of patients with either taxane or anthracycline based therapy. Methods: Open-label, multicenter, phase III study prospectivelly randomising to adjuvant chemotherapy with 4 cycles of Epirubicin 90 mg/m2 and Cyclophosphamide 600 mg/m2 q3w followed by 4 cycles of Docetaxel 100 mg/m2 q3w (EC-Doc) or 6 cycles of Epirubicin 60 mg/m2 i.v. d 1+8, 5-Fluorouracil 500 mg/m2 i.v. d 1+8 and Cyclophosphamide 75 mg/m2 p.o. d 1–14, q4w. Patients with positive hormone receptor status will receive endocrine therapy, and all patients will be required to receive adjuvant radiotherapy. Results: On 30/09/04 1202 pts. have been randomised in 195 recruiting centers. Primary tumor characteristics like tumor size (p = .24), axillary lymph node status (p = .84) and hormone receptor status (p = .78) were well balanced between both therapy arms. The tumor size of 28% of the pts. has been under 2cm, 59% of pts. had a tumor size of 2 cm to 5 cm. 46,9% were low differentiated (G 3). 60,2% of the pts. had 4–9 lymph nodes involved, while 39,8% presented more than 10 afflicted lymph nodes. In 83,5%, radiotherapy was performed after the completion of all chemotherapy cycles, in 16,5% radiotherapy was performed after completing half of the chemotherapy cycles. Serious adverse events were associated in 4,7% of all cycles, but most of the time not in causal relation. In the adjunct scientific program, the predictive value of uPA/PAI-1 on the primary tumor and of disseminated tumor cells in the bone marrow at primary diagnosis and after completion of chemotherapy is investigated. Conclusions: The excellent recruitment and the limited amount of complications confirm the uncomplicated accomplishment and good feasibility of this trial. The ADEBAR-Study will contribute further information on the role of taxanes in the adjuvant setting of high risk breast cancer patients. No significant financial relationships to disclose.