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https://www.readbyqxmd.com/read/28213365/fda-approval-summary-tas-102
#1
Leigh Marcus, Steven J Lemery, Sachia Khasar, Emily Wearne, Whitney S Helms, Weishi Yuan, Kun He, Xianhua Cao, Jingyu Yu, Hong Zhao, Yaning Wang, Olen Stephens, Erika Englund, Rajiv Agarwal, Patricia Keegan, Richard Pazdur
FDA approved TAS-102 (Lonsurf, Taiho Oncology, Inc.) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In an international, multicenter, double-blinded, placebo-controlled trial (TPU-TAS-102-301, herein referred to as RECOURSE), 800 patients with previously treated mCRC were randomly allocated (2:1) to receive either TAS-102 35mg/m2 orally twice daily after meals on Days 1-5 and 8-12 of each 28-day cycle (n=534) or matching placebo (n=266)...
February 17, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28209749/efficacy-and-safety-of-folfiri-regimen-in-elderly-versus-nonelderly-patients-with-metastatic-colorectal-or-gastric-cancer
#2
Ji-Won Kim, Keun-Wook Lee, Kyu-Pyo Kim, Ju Hyun Lee, Yong Sang Hong, Jeong-Eun Kim, Sun Young Kim, Sook Ryun Park, Byung-Ho Nam, Sang-Hee Cho, Ik-Joo Chung, Young Suk Park, Ho-Suk Oh, Myung-Ah Lee, Hye Jin Kang, Young Iee Park, Eun-Kee Song, Hye Sook Han, Kyu Taeg Lee, Dong Bok Shin, Jung Hun Kang, Dae Young Zang, Jee Hyun Kim, Tae Won Kim
BACKGROUND: Irinotecan-based chemotherapy is a standard backbone of therapy in patients with metastatic colorectal cancer (CRC) or gastric cancer (GC). However, there is still a paucity of information concerning the efficacy and safety of irinotecan-based regimens in elderly patients. PATIENTS AND METHODS: Using the patient cohort (n = 1,545) from the UGT1A1 genotype study, we compared the efficacy and safety between elderly and nonelderly patients with metastatic CRC (n = 934) or GC (n = 611) who received first- or second-line FOLFIRI (irinotecan, leucovorin, and 5-fluorouracil) chemotherapy...
February 16, 2017: Oncologist
https://www.readbyqxmd.com/read/28196905/a-phase-i-iia-study-of-dhp107-a-novel-oral-paclitaxel-formulation-in-patients-with-advanced-solid-tumors-or-gastric-cancer
#3
Min-Hee Ryu, Baek-Yeol Ryoo, Tae Won Kim, Sung Bae Kim, Hyeong-Seok Lim, Kyun-Seop Bae, Sook Ryun Park, Yeong-Woo Jo, Hyun Ju Cho, Yoon-Koo Kang
LESSONS LEARNED: Ideally, patients should have access to an oral formulation of paclitaxel, as well as an intravenous formulation, to allow development of regimens exploring alternate schedules and to avoid reactions to Cremophor EL (BASF Corp., Ludwigshafen, Germany, https://www.basf.com).DHP107 is a novel oral paclitaxel formulation that is a tolerable and feasible regimen for patients with gastric cancer, with data suggesting efficacy similar to that of intravenous paclitaxel. BACKGROUND: We evaluated the maximum tolerated dose (MTD) of DHP107, a novel oral paclitaxel formulation, and the efficacy and safety of the agent in patients with advanced solid tumors...
February 14, 2017: Oncologist
https://www.readbyqxmd.com/read/28185792/randomized-phase-iii-study-of-docetaxel-plus-cisplatin-versus-pemetrexed-plus-cisplatin-as-first-line-treatment-of-nonsquamous-non-small-cell-lung-cancer-a-trail-trial
#4
Cheol-Kyu Park, In-Jae Oh, Kyu-Sik Kim, Yoo-Duk Choi, Tae-Won Jang, Youn-Seup Kim, Kwan-Ho Lee, Kyeong-Cheol Shin, Chi Young Jung, Sei-Hoon Yang, Jeong-Seon Ryu, Seung-Hun Jang, Seung-Soo Yoo, Suk-Joong Yong, Kye Young Lee, Kwang-Ho In, Min-Ki Lee, Young-Chul Kim
INTRODUCTION: To date, no prospective phase III trials have directly compared the efficacy of pemetrexed plus cisplatin (Pem-Cis) with docetaxel plus cisplatin (Doc-Cis) in patients with nonsquamous non-small-cell lung cancer. MATERIALS AND METHODS: A total of 148 chemotherapy-naive patients lacking driver mutations were randomized into 21-day regimens of cisplatin 70 mg/m(2) with either docetaxel 60 mg/m(2) (n = 71) or pemetrexed 500 mg/m(2) (n = 77) for ≤ 4 cycles...
January 11, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28181415/a-phase-ii-trial-of-concurrent-chemotherapy-with-intravenous-cisplatin-and-vinorelbine-and-radiotherapy-followed-by-consolidation-chemotherapy-with-oral-vinorelbine-in-locally-advanced-non-small-cell-lung-cancer-nsclc-the-concave-study
#5
Brett Gm Hughes, Elizabeth Ahern, Margot Lehman, Gary Pratt, Margaret Dauth, Wendy Pritchard, Leesa Wockner, Keith Horwood
AIM: Despite recent advances, outcomes for patients with stage III non-small cell lung cancer (NSCLC) with concurrent chemoradiotherapy (CRT) remain poor. We evaluated the combination of ciplatin/vinorelbine and concurrent thoracic radiotherapy followed by consolidation oral vinorelbine in this phase II study. METHODS: Eligible patients with unresectable stage III NSCLC received cisplatin intravenous (IV) 40 mg/m(2) and vinorelbine IV 20 mg/m(2) on days 1, 8, 22 and 29 concurrent with thoracic radiotherapy of 60 Gy in 30 fractions...
February 9, 2017: Asia-Pacific Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28179353/carboplatin-plus-weekly-paclitaxel-combined-with-bevacizumab-as-first-line-treatment-for-non-small-cell-lung-cancer
#6
Masahiro Yamasaki, Isao Murakami, Kikuo Nakano, Mihoko Doi, Souichi Kitaguchi, Tomohiro Kondo, Joji Sakurai, Noboru Hattori, Ken-Ichi Arita
AIM: We aimed to evaluate the efficacy and safety of carboplatin plus weekly paclitaxel with bevacizumab in patients with advanced non-squamous non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients with stage IIIB/IV or postoperative recurrent NSCLC (n=33) were treated with carboplatin (area under the curve of 6) on day 1; paclitaxel (80 mg/m(2)) on days 1, 8, and 15; and bevacizumab (15 mg/kg) on day 1 repeated every 4 weeks, for four to six cycles; followed by maintenance bevacizumab (15 mg/kg) every 3 weeks...
2017: Anticancer Research
https://www.readbyqxmd.com/read/28161323/a-multicenter-phase-i-study-of-cabazitaxel-mitoxantrone-and-prednisone-for-chemotherapy-na%C3%A3-ve-patients-with-metastatic-castration-resistant-prostate-cancer-a-department-of-defense-prostate-cancer-clinical-trials-consortium-study
#7
Rahul Aggarwal, Alan Bryce, Charles J Ryan, Andrea Harzstark, Christina Derleth, Won Kim, Terence Friedlander, Amy M Lin, Tammy Rodvelt-Bagchi, Mallika Dhawan, Li Zhang, Mina Lee, Eric Siebeneck, Jeffrey Hough, Eric J Small
BACKGROUND: Cabazitaxel plus prednisone has significant activity in patients with chemotherapy-naïve and pretreated metastatic castration-resistant prostate cancer (mCRPC). Mitoxantrone has antitumor activity in mCRPC and nonoverlapping mechanism of action and toxicity profile. OBJECTIVE: To establish the maximally tolerated dose of the combination of cabazitaxel, mitoxantrone, and prednisone. METHODS AND MATERIALS: Patients with chemotherapy-naïve mCRPC were prospectively enrolled in a multicenter phase 1 trial...
February 1, 2017: Urologic Oncology
https://www.readbyqxmd.com/read/28159490/chemohormonal-therapy-in-metastatic-hormone-sensitive-prostate-cancer-sweeney-cj-chen-yh-carducci-m-liu-g-jarrard-df-eisenberger-m-wong-yn-hahn-n-kohli-m-cooney-mm-dreicer-r-vogelzang-nj-picus-j-shevrin-d-hussain-m-garcia-ja-dipaola-rs-department-of-medicine
#8
Eggener Scott
BACKGROUND: Androgen deprivation therapy (ADT) has been the backbone of treatment for metastatic prostate cancer since the 1940s. We assessed whether concomitant treatment with ADT plus docetaxel would result in longer overall survival than that with ADT alone. METHODS: We assigned men with metastatic, hormone-sensitive prostate cancer to receive either ADT plus docetaxel (at a dose of 75mg per square meter of body-surface area every 3wk for 6 cycles) or ADT alone...
February 1, 2017: Urologic Oncology
https://www.readbyqxmd.com/read/28152932/national-comprehensive-cancer-network-petitions-submissions-and-outcomes
#9
Dinah Faith Huff, William J Hrushesky, Charles Lee Bennett, Kevin Knopf, Michael Baum
: 248 Background: The National Comprehensive Cancer Network (NCCN) invites petitions to its scientific panels. Most ( > 95%) are from the pharmaceutical industry lobbying to include their products in the NCCN Guidelines. Rarely, physicians request scientific scrutiny of the guidelines. We report the experience of Oncology Analytics (OA) with petition submissions and the possible impact on guidelines. METHODS: From 2011-2015, OA made 7 petitions to NCCN. The content of each was tracked into subsequent NCCN Guidelines to ascertain whether any changes resulted...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28152926/cancer-care-decision-support-for-wbc-growth-factors-gf-geographic-differences-in-utilization-and-provider-malleability
#10
Kenneth Sherman Wurtz, Anna DiMarco, Lourdes Feliciano, Dinah Faith Q Huff, Kevin B Knopf, William J Hrushesky, Michael Baum
: 128 Background: Growth factor use is the largest single category of drug expenditure for US cancer patients. Oncology Analytics is a decision support company that assists physicians in determining the appropriate use of GF based on the NCCN, ASCO, and ASH guidelines and the level one data that underlies these guidelines. We hypothesized that there would be geographic variation among GF preference and in the malleability of those practice patterns after OA entered a market. We determined the proportion of initial pegfilgrastim requests for preauthorization over other types of GF as well as the review outcomes and final drug of choice after OA intervention of inappropriate GF requests across three specific jurisdictions: Florida, Puerto Rico, Georgia and Texas...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28152910/choosing-wisely-in-oncology-are-we-ready-for-value-based-care
#11
Doug Blayney, Mohammad Jahanzeb, Pamela Kadlubek, August Knape, Merry Jennifer Markham, Trang Pham, Tracey L Evans
: 275 Background: The Choosing Wisely (CW) Campaign challenges patients, healthcare providers, and specialty disease societies to make better decisions about healthcare delivery. In 2012, Schnipper et al. published ASCO's Top Five List targeting overuse of medications, tests, and procedures that are costly and lack evidence. 1.) Do not use cancer-directed therapy for patients with low performance status (undocumented, 3 or 4). 2.) Do not use PET, CT and radionuclide bone scans in the staging of early prostate cancer...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28152881/setting-quality-improvement-priorities-for-women-receiving-systemic-therapy-st-for-early-stage-breast-cancer-ebc-using-population-level-administrative-data
#12
Lingsong Yun, Alejandro Gonzalez, Melanie Powis, Nathan Taback, Christopher M Booth, Maureen E Trudeau, Monika K Krzyzanowska
: 299 Background: Routine evaluation of evidence informed quality measures (QM) can drive improvement in cancer systems by highlighting potential gaps in care. Targeting quality improvement at QMs that demonstrate substantial variation has the potential to make the largest impact on quality at a population level. We aimed to use variation in performance to set priorities for improving the quality of ST for women with EBC. METHODS: EBC cases diagnosed 2006 - 2010 in Ontario, Canada were identified in the Ontario Cancer Registry and linked deterministically to multiple health care databases...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28152742/prophylactic-use-of-granulocyte-colony-stimulating-factors-g-csf-in-cancer-patients-adherence-to-nccn-guidelines
#13
Vyshak Alva Venur, Shraddha Narechania, Paul Elson, Hamed Daw, Timothy Peter Spiro, Abdo Haddad
: 209 Background: G-CSF are used for prophylactic and therapeutic treatment of febrile neutropenia (FN). NCCN guidelines (version 1.2015) recommend prophylactic use of G-CSF based on the chemotherapy regimen and patient related risk factors, especially for the high (> 20%) and intermediate (10-20%) risk groups for developing FN. This study investigates the practice patterns and adherence to NCCN guidelines for use of G-CSF at a community based academic outpatient facility. METHODS: Cleveland Clinic IRB was obtained...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28152679/better-utilization-of-neutropenic-precautions-and-adherence-to-guidelines-to-improve-cost-effectiveness-and-patient-convenience
#14
Shada Attraplsi, Yehuda Z Lebowicz
: 227 Background: Cancer patient are generally immunocompromised and are at increased risk of infections once absolute neutrophils count is less than 500. The aim of the study to evaluate the inpatient utilization of a standardized neutropenic precautions in cancer patients admitted with febrile neutropenia. METHODS: From Jan 2010 to May 2015, established cancer patients were included in this retrospective study who were admitted in Cabel Huntington hospital, Huntington, WV with a diagnosis of febrile neutropenia and were placed on Neutropenic precautions (NP)...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28150022/efficacy-and-safety-of-neoadjuvant-chemotherapy-with-oxaliplatin-5-fluorouracil-and-levofolinate-for-t3-or-t4-stage-ii-iii-rectal-cancer-the-fact-trial
#15
Junichi Koike, Kimihiko Funahashi, Kazuhiko Yoshimatsu, Hajime Yokomizo, Hayato Kan, Takeshi Yamada, Hideyuki Ishida, Keiichiro Ishibashi, Yoshihisa Saida, Toshiyuki Enomoto, Kenji Katsumata, Masayuki Hisada, Hirotoshi Hasegawa, Keiji Koda, Takumi Ochiai, Kazuhiro Sakamoto, Hiroyuki Shiokawa, Shimpei Ogawa, Michio Itabashi, Shingo Kameoka
PURPOSE: A multicenter phase II clinical study was performed in patients with T3 or T4 stage II/III rectal cancer to evaluate the efficacy and safety of neoadjuvant chemotherapy with 5-fluorouracil, levofolinate, and oxaliplatin (mFOLFOX6). METHODS: Patients received four 2-week cycles of mFOLFOX6 therapy (oxaliplatin at 85 mg/m(2) + leucovorin at 200 mg/m(2) + fluorouracil as a 400 mg/m(2) bolus followed by infusion of 2400 mg/m(2) over 46 h, all on Day 1)...
February 1, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28138828/phase-i-ii-study-of-docetaxel-combined-with-resminostat-an-oral-hydroxamic-acid-hdac-inhibitor-for-advanced-non-small-cell-lung-cancer-in-patients-previously-treated-with-platinum-based-chemotherapy
#16
Yuichi Tambo, Yukio Hosomi, Hiroshi Sakai, Naoyuki Nogami, Shinji Atagi, Yasutsuna Sasaki, Terufumi Kato, Toshiaki Takahashi, Takashi Seto, Makoto Maemondo, Hiroshi Nokihara, Ryo Koyama, Kazuhiko Nakagawa, Tomoya Kawaguchi, Yuta Okamura, Osamu Nakamura, Makoto Nishio, Tomohide Tamura
Objectives To determine the recommended dose and efficacy/safety of docetaxel combined with resminostat (DR) in non-small cell lung cancer (NSCLC) patients with previous platinum-based chemotherapy. Materials and Methods A multicenter, open-label, phase I/II study was performed in Japanese patients with stage IIIB/IV or recurrent NSCLC and prior platinum-based chemotherapy. The recommended phase II dose was determined using a standard 3 + 3 dose design in phase I part. Resminostat was escalated from 400 to 600 mg/day and docetaxel fixed at 75 mg/m(2)...
January 30, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28133212/-use-of-pegfilgrastim-in-adjuvant-and-neoadjuvant-chemotherapy-for-breast-cancer
#17
Noriko Abe, Tohru Ohtake, Sadahiko Abe, Keita Aoto, Maiko Okano, Kazunoshin Tachibana, Seiich Takenoshita
We assessed the incidence of febrile neutropenia(FN), infection, and relative dose intensity(RDI)with or without the use of pegfilgrastim in breast cancer patients receiving adjuvant or neoadjuvant chemotherapy. Twenty-five patients received 4 cycles of FEC(5-FU 500mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 100 mg/m2 q3w)followed by 4 cycles of docetaxel(75mg/m2 q3w). Ten patients were administered pegfilgrastim as primary prophylaxis throughout all cycles of chemotherapy, and 15 patients were not...
November 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28133055/-analysis-of-the-risk-factors-of-febrile-neutropenia-among-72-women-receiving-fec-in-early-breast-cancer-chemotherapy
#18
Natsumi Ishii, Toshihiko Fujimori, Takahiro Kasagawa, Ikuo Udagawa
In early breast cancer chemotherapy, it is important to maintain the relative dose intensity(RDI). We retrospectively ana- lyzed the incidence and risk factors of febrile neutropenia(FN)among women receiving FEC(5-fluorouracil 500mg/m2, epirubicin 100mg/m2, and cyclophosphamide 500 mg/m2)chemotherapy. Of 72 patients, 33 patients developed FN and 39 patients did not. Excluding patients in whom the nadir could not be confirmed, we classified a final total of 28 patients into the FN group and 24 into the non-FN group...
November 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28122890/efficacy-of-reduced-dose-of-pegfilgrastim-in-japanese-breast-cancer-patients-receiving-dose-dense-doxorubicin-and-cyclophosphamide-therapy
#19
Yoshio Mizuno, Hiromi Fuchikami, Naoko Takeda, Masaru Iwai, Kazuhiko Sato
BACKGROUND: This retrospective study aimed to evaluate the efficacy of a 3.6-mg dose of pegfilgrastim for primary prophylaxis in Japanese breast cancer patients receiving dose-dense chemotherapy. METHODS: Patients treated with adjuvant or neoadjuvant chemotherapy for early-stage breast cancer at the Tokyo-West Tokushukai Hospital were included in this analysis. Because 6 mg pegfilgrastim has not yet been approved for use in Japan, we compared the outcomes of a dose-dense doxorubicin and cyclophosphamide regimen plus 3...
January 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28122294/quantification-of-ec-18-a-synthetic-monoacetyldiglyceride-1-palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol-in-rat-and-mouse-plasma-by-liquid-chromatography-tandem-mass-spectrometry
#20
Heon-Min Ryu, Yoo-Seong Jeong, Chang-Soon Yim, Jong-Hwa Lee, Suk-Jae Chung
EC-18 (i.e., 1-palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol), an active ingredient in Rockpid(®), has been reported to be useful in controlling various types of inflammations, particularly those caused by neutropenia. Although this product was originally approved as a functional food in Korea, it is currently in phase II clinical trials for use in managing the severe chemotherapy-induced neutropenia in patients with advanced breast cancer who are receiving intermediate febrile neutropenia risk chemotherapy...
January 17, 2017: Journal of Pharmaceutical and Biomedical Analysis
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