Latest clinical research advances in cytoxixaly

, June 1, 2007, the 43rd American Society for ClinicalOncology(ASCO) was held in Chicago, USAIn the excellent academic reports, the progress of clinical research on cytoxixade attracted a large number of participants' attention, and now a brief introduction to the four representative studiesThe results of the EXTREMEIII phase studythe multi-center, random phase III studies conducted by Vermorken et alshowed that adding sitoxibix (Erbitux, Ebitto) to the first-line treatment of platinum could extend the survival time of patients with recurrent or metastatic head and neck squamous cell carcinoma (SCCHN)J Clin Oncol 2007, 25 (18: 6091)previous trials have shown that epidermal growth factor receptors (EGFR) are expressed in almost all SCCHN patients, meaning that SCCHN can be treated with EGFR-targeted drugs such as sitoxishi monotomatox(Burtness, et alJ Clin Oncol 2005, 23:5440; Bourhis, et alJ Clin Oncol 2006, 24:2866)Vermorken et al
.)The case in this study was included in thestandard : III-IV recurrence and/or metastatic SCCHN, and is not suitable for topical radiation therapy The 442 patients in the study were randomly divided into two groups: group A patients (n-222) taking sytoxaxaxon (initial dose: 400 mg/m
2 , followed by 250 mg/m 2 ) per week, plus cisplatin (day 1 intravenous infusion 100 mg/m
2 ) or calplatin (Day 1 AUC) 5) 5- FU (1000 mg/m
2 daily continuous intravenous infusion for 4 days), 3 weeks for 1 course of treatment, up to 6 courses of treatment, group B patients (n-220) using the same use of cisplatin or caipita and 5-FU, when patients can not tolerate chemotherapy toxicity or disease progression the use of sytoximono The main endpoints of the study were total survival time (OS); secondary endpoints included: disease-free survival, efficiency, disease control rate, safety and patient quality of life Stratification factors at randomization included prior chemotherapy (at least 6 months before entering the group if the patient received local late-stage SCCHN treatment) and the Quality of Life Score (KPS) 80 and KPS 80 results showed that 442 patients were randomly grouped in 35 regions of Europe within one year The baseline characteristics of the A and B groups included: male and female ratio 399/43, median age 57 years (33-80 years old), median KPS score 80 (50 to 100), and past treatment including surgery, radiotherapy (RT), induced chemotherapy or chemotherapy combined with radiotherapy The main high incidence of tumor was the pharynx (47%), followed by the throat (25%) The survival analysis showed that the median survival time of patients with simple chemotherapy (Group B) was 7.4 months, the median survival time of chemotherapy and cytoximatic monoidatis (Group A) was 10.1 months, and there was a significant difference between the two groups (P-0.036) Conclusion: Compared with standard chemotherapy, chemotherapy and sitoxitaminis have clinical benefits for patientsurvival 10.1 months is the longest survival time observed in Phase III trials Analysis of the secondary endpoint is ongoing Crystal Phase III results The results of a randomized Phase III clinical trial conducted by Van Cutsem et al showed that Theilitcon 5-FU-folate calcium (FA), or FOLFIRI, combined with the treatment of cytoxitamin first-line treatment metastatic colorectal cancer (mCRC), significantly prolonged patient severity of progression survival (PFS) (J Clin Oncol 2007,25 (18:4000) in patients with mCRC who have been treated in the past, the combination of sitoxisionaxaform-based treatment has been proven to be effective The study was designed to compare the efficacy of sitoxiifil in combination with standard chemotherapy regimen and purely to treat EGFR-positive mCRC patients with FOLFIRI first line of treatment Patients were randomly divided into A and B groups according to 1:1 Group A received sitoxiific monotomatox (initial dose: 400 mg/m
2 , followed by 250 mg/m 2 ) and 1 folFIRI (Ilitikon 180 mg/m
2 , FA 400 mg/m
2 per 2 weeks, 5-FU quickly push 400 mg/m 2 , followed by 46 hours of intravenous infusion 2400 mg/m
2 ); The primary endpoint is progression-free survival, and secondary endpoints include total lifetime, efficiency (RR), disease control rate, and safety The results showed that from August 2004 to October 2005, 1217 patients were randomly grouped, 608 were grouped into Group A, and 609 were divided into group B (60 per cent of all patients were male , median age 61 years old, ECOG-PS score: 54 per cent, 1 out of 43.5 and 2.5 per cent Compared with Group B, the median PFS was significantly longer (8.9 months vs 8 months, P-0.036); Both groups were well tolerated, with the main levels 3 to 4 adverse reactions including: neutrophil aphnopathy (Group A: 26.7%, Group B: 23.3%), Diarrhea (Group A: 15.2%, Group B: 10.5%), Skin Reaction (Group A: 18.7%, Group B: 0.2%) Conclusion: The combination of cytoxixades and FOLFIRI can significantly increase the patient's RR, significantly extend PFS in patients receiving first-line treatment mCRC, and reduce the relative risk of disease progression by about 15% The side effects associated with combination therapy are the expected moderate diarrhea and more skin reactions than pure FOLFIRI alone The EPIC III study results Maurel et al is an international multicenter Phase III clinical study designed to observe the efficacy of sitoxisedumin and Gailiticon on patients who have previously failed treatment based on oshariplatin The results of the study showed that cytoximatoxade sylyxametalycon could significantly improve PFS and RR in mCRC patients and better maintain the quality of life of patients J Clin Oncol 2007,25 (18:4003) The purpose of the EPICIII phase clinical trial was to detect the survival effects of sitoxiumain on patients with metastatic colorectal cancer (mCRC) who were positive for pre-treatment EGFR expression Patients were randomly assigned to the sytoxi-monoidatin (initial dose: 400 mg/m
2 , followed by 250 mg/m 2 per week) and Iliticon (350 mg/m
2 , 1 time every 3 weeks) in combination treatment group and alone using the Iletikon group The main endpoint is Total Lifetime (OS), and one of the secondary endpoints is quality of life The European Cancer Research And Therapeutics Group (EORTC) QLQ-C 30 3.0 to assess the health -related quality of life (HRQoL) of the patients in the trial Pre-treatment patients completed the questionnaire and followed patients at the first follow-up and every two courses (3 weeks each) The Wei-Lachin test was used to compare HRQoL in two groups of patients The results showed that the demographic characteristics of the baseline of the two groups of patients were similar The Situxi singantis and Ilitikon group (n-648) are superior to the single-use Iletikon group (n-650) in PFS (HR:0.69, P 0.0001), RR (16.4% vs 4.2%, P 0.0001) Although the two groups of OS are comparable, but the two groups of OS are equivalent, but because Of Iletikone is used alone Forty-six percent of the cases in the group received sytoxaxatosa, 89 percent of which were used in combination with Ileticon, so the two groups of OS results may be affected by this cross-treatment There was no significant difference in HRQoL scores at baseline, but overall health status, function, function, role, mood, cognition, and symptoms (weakness, nausea or vomiting, pain) were significantly different after treatment And the score is favorable to the Sitoxi sing-in-conjunction Ilithikang group Compared to the Iliticon group, the sitoxixalysa-Iliticon group scored higher on 10 of the 15 HRQoL sitems, and there were significant differences in global health status scores, pain, nausea (P.047, P 0.0001, P.0001, P.00 0001.
in short, there were significant differences in the improvement of PFS and RR in the cytoxixamcine-combined Iliticon group and the use of Elithion group alone, and the combined treatment group was able to better maintain HRQoL, with less clinical symptoms (pain, nausea, insomnia) worsening, and overall health scores remaining good The results of the Multi-Center Phase II study conducted by the Gastrointestinal Tumor Research Group (AIO
) Lordick et al showed that the first-line treatment of metastatic gastric cancer was effective in the first line of the sitoxisizumab-plus-weekly FUFOX programme (Oshalip-5-FU-FA) (J Clin Oncol 2007,25 (18:4526) previous clinical studies have confirmed that cytoximatoma and FUFOX combined with first-line treatment of mCRC are effective Lordick evaluated the efficacy of the joint programme in the treatment of advanced stomach cancer Selected patients with the 1st intravenous infusion of 400 mg/m
2 , followed by 250 mg/m 2 per week and joint lying with the FUFOX programme (Oshaliplatin 50 mg/m
2
plus 5-FU 2000 mg/m
2
and DL FA 200 mg/m
2 d
1
, 8,15
,22qd3
The main endpoint of the study was to evaluate efficacy according to the RECIST standard The toxic response to the treatment is reported according to the National Cancer Institute (NIC) CTC 3.0 version The results showed that from April 2005 to March 2006, 13 were women , 39 were male , median age 63 (38-80 years old), 19 patients with ECOG-PS score 0, 25 cases with a score of 1, and 8 cases with a score of 2 The median number of affected organs was 3 (1 to 5): 46% of the liver and 31% of the peritoneal The total effectiveness of 46 assessable cases was 65.2% (95% CI: 49.8 to 78.6), including 4 cases of full remission and 26 partial remission, of which 18 patients were confirmed The effective rate of patients with no EGFR was 76.5% and the effective rate of EGFR patients could be detected was 54.2% Intentional therapy (ITT) analysis showed that the progression time of the median disease (TTP) was 7.6 months (95% CI: 5.0 to 10.1) and the median survival time (OS) was 9.5 months (95% CI: 7.9 to 11.1) In summary, sitoxiific supamcinous plus FUFOX is effective for metastatic gastric cancer regardless of the results of the IHC detection of EGFR