FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2022095987> ?p ?o ?g. }

• W2022095987 endingPage "238" @default.
• W2022095987 startingPage "232" @default.
• W2022095987 abstract "<i>Background:</i> Cisplatin (CDDP) is among the most active single agents against squamous cell carcinoma of the head and neck (SCCHN), and it is still the reference drug in the induction chemotherapy setting, when used in combination with infusional 5-fluorouracil (5-FU). Raltitrexed has been shown to be devoid of clinical activity against SCCHN when used alone; however, both preclinical and early clinical data regarding the combination raltitrexed-CDDP hold promise. Thymidylate synthase is the target enzyme of both raltitrexed and 5-FU; however, the two drugs have distinct sites of action on the enzyme and the combination of the two agents may be synergistic. We have previously shown that the combination of raltitrexed, levofolinic acid (LFA) and 5-FU has clinical activity against SCCHN; in a subsequent phase I study, cisplatin was added, and the combination of CDDP plus raltitrexed on day 1, followed by LFA and 5-FU on day 2, was judged feasible and active, since a 67% response rate was shown across all dose levels, with a 100% response rate at the recommended dose for phase II. <i>Methods:</i> Patients with inoperable locally advanced or metastatic SCCHN, not pretreated with chemo- or radiotherapy were randomized to receive either CDDP 60 mg/m² and raltitrexed 2.5 mg/m² on day 1 and LFA 250 mg/m² and 5-FU 900 mg/m² on day 2 (arm A) or CDDP 65 mg/m² and methotrexate 500 mg/m² on day 1, and LFA 250 mg/m² and 5-FU 800 mg/m² on day 2 (arm B). Both treatments were repeated every 2 weeks. Evaluation for tumor response was performed after four cycles. According to Simon two-stage design, with a target complete response (CR) rate (p1) of 35%, at least 7 CR among the first 31 treated patients and 16 CR among the final sample size of 52 patients were required. <i>Results:</i> An interim analysis was performed when 36 patients were evaluable in each arm. In arm A, 10 CR (28%) and 19 partial responses (PR) (53%) were observed, for an overall response rate of 81%. In arm B, 3 CR (8%) and 12 PR (34%) were observed, for an overall response rate of 42%. The difference in both CR and overall response rate between the two arms was statistically significant (p = 0.03 and <0.001, respectively). Therefore, the accrual was stopped in arm B and continued only in arm A. Overall, 13 CR (21%) and 34 PR (56%) were observed among the 61 patients who were accrued in arm A, for an overall response rate of 77% (95% confidence interval 64–87%). Neutropenia was the main side effect in both arms (grade 3–4 in 45 and 23 patients in arm A and B, respectively). Extrahematologic toxicity was mild in both arms; however, 2 patients in arm B died due to toxicity (grade 4 mucositis in one case, grade 4 renal toxicity in the other). <i>Conclusions:</i> Although response data for our experimental treatment look encouraging, the hypothesis of a 35% activity, expressed as capability to induce a CR, cannot be accepted. The results obtained in this study are not substantially different from those of other trials of CDDP-5-FU-based regimens, and our combination is unlikely to represent a major breakthrough when used in this setting." @default.
• W2022095987 created "2016-06-24" @default.
• W2022095987 creator A5013792017 @default.
• W2022095987 creator A5014792832 @default.
• W2022095987 creator A5040974455 @default.
• W2022095987 creator A5048054764 @default.
• W2022095987 creator A5056559714 @default.
• W2022095987 creator A5058301344 @default.
• W2022095987 creator A5073695437 @default.
• W2022095987 creator A5088304855 @default.
• W2022095987 date "2002-01-01" @default.
• W2022095987 modified "2023-09-25" @default.
• W2022095987 title "Cisplatin, Raltitrexed, Levofolinic Acid and 5-Fluorouracil in Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck: A Phase II Randomized Study" @default.
• W2022095987 cites W168693843 @default.
• W2022095987 cites W1935103070 @default.
• W2022095987 cites W1986884101 @default.
• W2022095987 cites W2011168038 @default.
• W2022095987 cites W2036409540 @default.
• W2022095987 cites W2049948758 @default.
• W2022095987 cites W2057544385 @default.
• W2022095987 cites W2070062790 @default.
• W2022095987 cites W2079567664 @default.
• W2022095987 cites W2079824176 @default.
• W2022095987 cites W2098098766 @default.
• W2022095987 cites W2104854477 @default.
• W2022095987 cites W2108522544 @default.
• W2022095987 cites W2109261874 @default.
• W2022095987 cites W2151616125 @default.
• W2022095987 cites W2152094258 @default.
• W2022095987 cites W2152609192 @default.
• W2022095987 cites W2237190276 @default.
• W2022095987 cites W2267854900 @default.
• W2022095987 cites W2333213712 @default.
• W2022095987 doi "https://doi.org/10.1159/000065470" @default.
• W2022095987 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/12381902" @default.
• W2022095987 hasPublicationYear "2002" @default.
• W2022095987 type Work @default.
• W2022095987 sameAs 2022095987 @default.
• W2022095987 citedByCount "16" @default.
• W2022095987 countsByYear W20220959872012 @default.
• W2022095987 countsByYear W20220959872018 @default.
• W2022095987 countsByYear W20220959872020 @default.
• W2022095987 countsByYear W20220959872021 @default.
• W2022095987 crossrefType "journal-article" @default.
• W2022095987 hasAuthorship W2022095987A5013792017 @default.
• W2022095987 hasAuthorship W2022095987A5014792832 @default.
• W2022095987 hasAuthorship W2022095987A5040974455 @default.
• W2022095987 hasAuthorship W2022095987A5048054764 @default.
• W2022095987 hasAuthorship W2022095987A5056559714 @default.
• W2022095987 hasAuthorship W2022095987A5058301344 @default.
• W2022095987 hasAuthorship W2022095987A5073695437 @default.
• W2022095987 hasAuthorship W2022095987A5088304855 @default.
• W2022095987 hasConcept C123321153 @default.
• W2022095987 hasConcept C126322002 @default.
• W2022095987 hasConcept C143998085 @default.
• W2022095987 hasConcept C2776530083 @default.
• W2022095987 hasConcept C2776694085 @default.
• W2022095987 hasConcept C2778239845 @default.
• W2022095987 hasConcept C2779268555 @default.
• W2022095987 hasConcept C2780456651 @default.
• W2022095987 hasConcept C31760486 @default.
• W2022095987 hasConcept C509974204 @default.
• W2022095987 hasConcept C71924100 @default.
• W2022095987 hasConceptScore W2022095987C123321153 @default.
• W2022095987 hasConceptScore W2022095987C126322002 @default.
• W2022095987 hasConceptScore W2022095987C143998085 @default.
• W2022095987 hasConceptScore W2022095987C2776530083 @default.
• W2022095987 hasConceptScore W2022095987C2776694085 @default.
• W2022095987 hasConceptScore W2022095987C2778239845 @default.
• W2022095987 hasConceptScore W2022095987C2779268555 @default.
• W2022095987 hasConceptScore W2022095987C2780456651 @default.
• W2022095987 hasConceptScore W2022095987C31760486 @default.
• W2022095987 hasConceptScore W2022095987C509974204 @default.
• W2022095987 hasConceptScore W2022095987C71924100 @default.
• W2022095987 hasIssue "3" @default.
• W2022095987 hasLocation W20220959871 @default.
• W2022095987 hasLocation W20220959872 @default.
• W2022095987 hasOpenAccess W2022095987 @default.
• W2022095987 hasPrimaryLocation W20220959871 @default.
• W2022095987 hasRelatedWork W1986634144 @default.
• W2022095987 hasRelatedWork W2046102541 @default.
• W2022095987 hasRelatedWork W2050131716 @default.
• W2022095987 hasRelatedWork W2161046978 @default.
• W2022095987 hasRelatedWork W2313027913 @default.
• W2022095987 hasRelatedWork W2406263212 @default.
• W2022095987 hasRelatedWork W2409439767 @default.
• W2022095987 hasRelatedWork W2418001928 @default.
• W2022095987 hasRelatedWork W2430773826 @default.
• W2022095987 hasRelatedWork W2460868461 @default.
• W2022095987 hasVolume "63" @default.
• W2022095987 isParatext "false" @default.
• W2022095987 isRetracted "false" @default.
• W2022095987 magId "2022095987" @default.
• W2022095987 workType "article" @default.