scholarly journals Xeloda as first-line therapy of metastatic colorectal cancer-our experience

2002 ◽  
Vol 10 (4) ◽  
pp. 249-252
Author(s):  
Vladimir Kovcin ◽  
Rada Jesic ◽  
Zoran Krivokapic ◽  
Zoran Andric ◽  
Aleksandra Pavlovic
Keyword(s):  
Liver Function ◽  
Adverse Events ◽  
Liver Dysfunction ◽  
Primary Tumor ◽  
Response Rate ◽  
Phase Iii ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference

BACKGROUND: Results of phase III clinical studies comparing efficacy of Xeloda vs. standard 5-FU/FA protocols as first line therapy of metastatic colorectal carcinoma (MCRC), have shown better efficacy of Xeloda, with less toxic adverse effects, apart from handfoot syndrome. METHODS: From January 2000 to May 2001 the study enrolled 54 patients with MCRC, 38 males and 16 females, aged 30-78 years. All patients had metastatic diseases. In 33 the primary tumor was in colon, in 21 in rectum. All patients received Xeloda 2500 mg/m2/day in two daily doses, during 14 days followed by 7 days of pause. Dose intensity was 88,79% +/- 9,2. For efficacy evaluation the WHO criteria and tumor markers CEA and CA 19-9 were used. RESULTS: Overall response rate was 47%, with 13% complete responses, 34% partial responses 38% stable disease and 15% disease progression. No significant difference was found between patients with regard to localization of primary tumor (colon or rectum). There was no significant difference in response rate when compared 27 patients with adverse events of capecitabine ('hand and foot' syndrome and diarrhea) and those without them. Response rate in a subgroup of 21 evaluable (out of 29) patients with initial signs of liver dysfunction was worse (p<0.005) in comparison with patients with normal liver function. Most frequent adverse events were 'hand and foot' syndrome (52%) and diarrhea (24%), or both (14%). Other adverse events, up to grade 2 toxicity, were sporadically reported; however, hematological toxicity was significantly more common in a subgroup of patients with compromised liver function (p<0.007). CONCLUSION: This study has shown that Xeloda is a good monotherapy choice, with high response rate as first line therapy of metastatic CRC. Adverse events do not influence response. Liver dysfunction is a poor prognostic parameter. Therapy with Xeloda is convenient and relatively safe in patients with liver dysfunction, where administration of other cytotoxic agents is not possible.

Health related quality of life (HRQOL) evaluated with the EORTC C30 questionnaire in first line therapy of elderly patients with chronic lymphocytic leukemia (CLL): Results of a phase III trial of the German CLL Study Group (GCLLSG)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7572-7572 ◽  
Author(s):  
B. F. Eichhorst ◽  
R. Busch ◽  
M. Hallek
Keyword(s):  
Social Functioning ◽  
Age Groups ◽  
Lymphocytic Leukemia ◽  
Phase Iii ◽  
Response To Treatment ◽  
First Line ◽  
Elderly Age ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference

7572 Background: The GCLLSG evaluated the efficacy of fludarabine (F) versus (vs.) chlorambucil (Clb) in first line therapy of older patients with advanced CLL. HRQOL was evluated by using the EORTC C30 questionnaire. Methods: Pts were randomized to receive 6 courses of F (25 mg/m²/day (d) IV for 5d; 92 pts) or 12 months (mo) of Clb (0.4–0.8 mg/kg/d PO, every 15d; 99 pts). All pts were previously untreated, aged between 65 and 79 years and in advanced stage Binet C or symptomatic Binet B or A. Primary endpoints were overall survival (OS) and progression free survival (PFS), secondary endpoint was HRQOL. The EORTC C30 questionnaire (version 2.0) was sent to all patients at baseline and after 6, 12 and 24 mo. Scores (0–100) for 15 different measures (1 global HRQOL, 5 functional, 3 symptom and 6 single item scales) were evaluated at each time point. Results: F induced significantly higher response rates and prolonged the PFS, while no significant difference in OS was observed. At baseline 130 of 191 pts (68%) completed the questionnaires followed by more than 80% at mo 6 to 24. Compliance rates were similar in both treatment arms. Between pts completing questionnaires or not no statistically significant differences in perfomance status, age, stage or response to treatment were observed. HRQOL differences in comparison to baseline values were significantly improved after F treatment in global HRQOL, role and social functioning after 12 months as shown by the table. Responders had a significantly better global HRQOL and social functioning as well. Except for an impaired physical functioning no differences in HRQOL were observed between different age groups (65–69, 70–74, 75–79). Conclusion: Elderly F treated patients with CLL showed improvement inglobal HRQOL. Elderly age groups had a similar HRQOL as younger age groups. [Table: see text] [Table: see text]

Phase III trial of lenvatinib (LEN) vs sorafenib (SOR) in first-line treatment of patients (pts) with unresectable hepatocellular carcinoma (uHCC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4001-4001 ◽  
Author(s):  
Ann-Lii Cheng ◽  
Richard S. Finn ◽  
Shukui Qin ◽  
Kwang-Hyub Han ◽  
Kenji Ikeda ◽  
...  
Keyword(s):  
Growth Factor ◽  
Adverse Events ◽  
Growth Factor Receptors ◽  
Phase Iii ◽  
Type I ◽  
Fibroblast Growth Factor Receptors ◽  
First Line ◽  
Phase Iii Trial ◽  
First Line Therapy ◽  
Line Therapy

4001 Background: SOR is the only approved agent in uHCC and new options are needed. LEN, an inhibitor of vascular endothelial growth factor receptors 1‒3, fibroblast growth factor receptors 1‒4, platelet derived growth factor receptor α, RET, and KIT, showed activity in uHCC in a phase II trial. We report a phase III trial of LEN vs SOR as first-line therapy for uHCC. Methods: In this randomized, open-label, noninferiority (NI) study, pts had uHCC, ≥ 1 measurable target lesion, Barcelona Clinic Liver Cancer stage B or C, Child-Pugh class A, ECOG PS ≤ 1, and no prior systemic therapy. Pts were randomized 1:1 to LEN (body weight ≥ 60 kg: 12 mg/day; < 60 kg: 8 mg/day) or SOR 400 mg twice daily. The primary endpoint was overall survival (OS). The OS hazard ratio (HR) and its 95% CI were estimated with a stratified Cox proportional hazard model. The predefined NI margin was 1.08. Secondary efficacy endpoints were progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR) by modified RECIST. Type I error rates for secondary efficacy endpoints were controlled with a fixed sequence procedure at 2-sided α = 0.05 after OS NI was claimed. Results: 954 Pts enrolled (LEN: 478; SOR: 476). Efficacy outcomes are shown in the table. A similar number of pts in both arms had treatment-emergent adverse events (TEAEs). Most common LEN TEAEs were hypertension (42%), diarrhea (39%), decreased appetite (34%), decreased weight (31%), and fatigue (30%). Median (range) treatment duration was 5.7 mos (0−35.0) for LEN and 3.7 mos (0.1−38.7) for SOR. 13% Of LEN-treated and 9% of SOR-treated pts discontinued due to adverse events. 33% Of LEN-treated and 39% of SOR-treated pts received second-line therapy. Conclusions: LEN is noninferior in OS, and achieves statistically significant and clinically meaningful improvements in PFS, TTP, and ORR, as first line therapy for uHCC. TEAEs were consistent with the known LEN safety profile. Clinical trial information: NCT01761266. [Table: see text]

Health-related quality of life (HRQoL) of pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: The phase III KEYNOTE-590 study.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 168-168
Author(s):  
Wasat Mansoor ◽  
Amit S. Kulkarni ◽  
Ken Kato ◽  
Jong-Mu Sun ◽  
Manish A. Shah ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Phase Iii ◽  
Advanced Esophageal Cancer ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Pain Subscale ◽  
Significant Difference ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

168 Background: In the randomized, international, double-blind, placebo-controlled KEYNOTE-590 (NCT03189719) study, pembrolizumab (pembro) + chemotherapy (chemo) provided statistically significant and clinically meaningful improvement in OS, PFS, and ORR vs placebo + chemo as first-line therapy for patients (pts) with locally advanced/unresectable or metastatic adenocarcinoma or esophageal squamous cell carcinoma (ESCC) or Siewert type 1 esophagogastric junction adenocarcinoma (EGJ). Here we report HRQoL outcomes in KEYNOTE-590. Methods: 749 pts were randomized 1:1 to pembro 200 mg or placebo Q3W for up to 2y + chemo (cisplatin 80 mg/m2 Q3W [d1; 6 doses] + 5-FU 800 mg/m2 on d1-5 Q3W). EORTC QLQ-C30, EORTC QLQ-OES18, and EQ-5D-5L questionnaires were administered at baseline, every 3 weeks (Q3W) up to week 24, and then Q9W up to 1 year or end of treatment, and at the 30-d safety follow-up visit. HRQoL was assessed in all treated patients who completed ≥1 HRQoL assessment (N = 711: 356 for pembro + chemo; 355 for chemo). Change from baseline to week 18 in EORTC-QLQ-C30 global health status (GHS)/QoL and physical functioning, and in QLQ-OES18 scores were prespecified secondary endpoints. Change from baseline to week 18 in EQ-5D scores was an exploratory endpoint. Time to deterioration (TTD) was evaluated for all endpoints. Least square mean (LSM) change from baseline (95% CI) was compared using a constrained longitudinal data analysis model. TTD was compared using a stratified log rank test and Cox proportional hazards model. P-values are nominal and two-sided. Results: QLQ-C30, QLQ-OES18 and EQ-5D-5L compliance was ≥90% in both arms at baseline and at week 18. There was no significant difference in least squares mean (LSM) change from baseline to week 18 in GHS/QoL status between arms (LSM difference [95% CI] -0.10 [-3.40-3.20]; P = 0.9530). Median TTD in GHS/QoL was similar between arms (HR, 0.86 [95% CI, 0.66-1.13]; P = 0.2864). Outcomes were similar in ESCC PD-L1 CPS ≥10, ESCC, and PD-L1 CPS ≥10 patient populations. LSM change from baseline to week 18 for QLQ-OES18 pain subscale was better for pembro + chemo (-4.78) vs chemo (-1.85 ) (-2.94, -5.86 to -0.02; P = 0.0487). There was no significant difference in LSM change from baseline to week 18 between arms for reflux (-1.19; -4.49-2.10; P = 0.4781) or dysphagia (-2.35; -7.78-3.07; P = 0.3945). VAS LSM change from baseline to week 18 was similar between arms (1.20, -1.61-4.01; P = 0.4016). Conclusions: HRQoL was stable and similar over 18 weeks in the pembro + chemo and chemo arms. Together with superior OS, PFS, and ORR and a manageable safety profile with pembro + chemo, these results support the clinically meaningful benefit of pembro + chemo in patients with advanced esophageal cancer including EGJ adenocarcinoma. Clinical trial information: NCT03189719.

Randomized phase II cross-over sequential chemotherapy trial of irinotecan/cisplatin (IP) vs. gemcitabine/vinorelbine (GV) in chemo-naïve patients with stage IIIb/IV non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7134-7134
Author(s):  
J. S. Lee ◽  
D. H. Lee ◽  
J. J. Lee ◽  
J. Y. Han ◽  
S. H. Park ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Stage Iiib ◽  
Second Line ◽  
Toxicity Profile ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Randomized Phase Ii ◽  
Significant Difference

7134 Background: To compare the efficacy and toxicity of IP vs. non-platinum-based GV in the treatment of advanced NSCLC, we conducted a randomized phase II trial with planned cross-over to the other regimen upon disease progression (PD) after the first-line therapy. Methods: Eligibility required stage IIIb/IV NSCLC, no prior chemotherapy, measurable disease, ECOG PS 0–2, adequate organ functions, and informed consent. After stratification by gender, stage (IIIB or IV) and performance status (PS: 0–1 or 2), eligible pts were randomized to receive either IP (I 65 mg/m2 & P30 mg/m2 on D1 & 8 q 3 weeks) first then GV (G 900 mg/m2 &V25 mg/m2 on D1 & 8 q 3 weeks) upon PD (Arm A) or GV first then IP upon PD (Arm B). Results: Between 12/2003 and 06/2005, 146 pts were enrolled in either Arm A (n = 75) or Arm B (n = 71). There was no difference in gender (male: 77.3% vs. 81.7%), age (median: 58 vs. 60 yrs), PS (PS 2: 10.7% vs. 8.5%), histology (adenocarcinoma: 72.0% vs. 76.6%) and stage (IV: 88.0% vs. 87.3%). IP tended to generate more responses than GN (42.0% vs. 29.0% as first-line, 30.2% vs. 14.3% as second-line), but there was no difference in total response rate by the treatment arm (Arm A: 45.6%, B: 43.5%). During the first-line therapy, IP caused more G3+ anemia (20.0% vs. 7.1%, p = 0.048), G2/3 nausea/vomiting (41.4% vs. 12.9%, p < 0.001), G2 alopecia (35.7% vs. 10.0%, p = 0.001) than GN while pneumonitis was noted only with GN (11.4%). Toxicity profile was similar after the second-line therapy. Both arms resulted in excellent survival outcome with no significant difference between the Arm A and B (median: 16.5 mo vs. 15.1 mo, p = 0.595). Conclusions: Platinum-based IP regimen seemed to be more effective in terms of response rate. Given the overall survival data and the mild toxicity profile of GV regimen, however, either treatment sequence seems to be acceptable for the treatment of advanced metastatic NSCLC. (Supported in part by NCC grants 0210140 and 0510140). No significant financial relationships to disclose.

5-azacytidine treatment results in myelodysplastic syndrome

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e18003-e18003
Author(s):  
S. M. Bakanay ◽  
E. Karakiliç ◽  
S. Civriz-Bozdag ◽  
M. Arat ◽  
M. Ozcan ◽  
...  
Keyword(s):  
Myelodysplastic Syndrome ◽  
Serum Ferritin ◽  
Response Rates ◽  
Phase Iii ◽  
International Prognostic Scoring System ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Significant Difference ◽  
Number Of Cycles

e18003 Background: Myelodysplastic syndrome (MDS) is a clonal disease of hematopoiesis characterized by dysplasia in one or more series. 5-azacytidine (5-AZA) which is one of the methyl transferase inhibitors, targets the epigenetic changes in MDS and has been used for the last few years. Phase III studies which compare 5-AZA with supportive therapies report response rates up to 60%. Methods: In this study the aim was to retrospectively analyze the response rates of 26 MDS patients who were treated with 5-AZA between years 2002–2008. The patients were; median age 58 (21–84); male/female = 16/10; RAEB-I (7 patients); RAEB-II (18 patients); ve CMML (1 patient); secondary MDS (2 patients). According to an international prognostic scoring system, 6 patients were intermediate-1; 9 patients were intermediate-2; and 11 patients were high risk. Nine patients received 5-AZA as first-line therapy. The median leukocyte counts, absolute neutrophil counts (ANC), hemoglobin values, and thrombocyte counts at the begining of the cycles were; 2.4 (0.5–23)x10e9/L, 0.7 (0.1–16.5)x10e9/L, 8.6(5.3–11.4) gr/dl, 41(4–35)x10e9/L, respectively. The karyotype analysis revealed del5q in 3 patients; -7/del7q in 6 patients; trisomy 8 in 7 patients, del20q, del11q and complex karyotype (del7q+del5q+delY) in 1 patient each. The median cycles completed were 2 (1–6). Results: Seven patient were not elligible for response evaluation. Nine patients (47%) did not respond to the therapy and 8 of them were lost. Ten patients (53%) responded to the therapy with complete remission (n=4), partial remission (n = 2) and hematological improvement (n = 4). The responders and non-responders were similar in terms of median age, sex and pretreatment leukocyte, ANC and hemoglobin levels. However, there was statistically significant difference in terms of initial thrombocyte counts, total number of cycles received and serum ferritin levels. The patients who received 5-AZA as first line therapy had beter response than others (71% versus 29%). Conclusions: The observed response to 5-AZA therapy was similar to the reported rates in the literature. The most important factors for response were initial thrombocyte counts, total number of cycles, other therapies received before 5-AZA and the serum ferritin levels. No significant financial relationships to disclose.

Weekly nab-Paclitaxel in Combination With Carboplatin Versus Solvent-Based Paclitaxel Plus Carboplatin as First-Line Therapy in Patients With Advanced Non–Small-Cell Lung Cancer: Final Results of a Phase III Trial

2012 ◽  
Vol 30 (17) ◽  
pp. 2055-2062 ◽  
Author(s):  
Mark A. Socinski ◽  
Igor Bondarenko ◽  
Nina A. Karaseva ◽  
Anatoly M. Makhson ◽  
Igor Vynnychenko ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Rate Ratio ◽  
Response Rate ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
First Line ◽  
Phase Iii Trial ◽  
First Line Therapy ◽  
Line Therapy

Purpose This phase III trial compared the efficacy and safety of albumin-bound paclitaxel (nab-paclitaxel) plus carboplatin with solvent-based paclitaxel (sb-paclitaxel) plus carboplatin in advanced non–small-cell lung cancer (NSCLC). Patients and Methods In all, 1,052 untreated patients with stage IIIB to IV NSCLC were randomly assigned 1:1 to receive 100 mg/m2 nab-paclitaxel weekly and carboplatin at area under the concentration-time curve (AUC) 6 once every 3 weeks (nab-PC) or 200 mg/m2 sb-paclitaxel plus carboplatin AUC 6 once every 3 weeks (sb-PC). The primary end point was objective overall response rate (ORR). Results On the basis of independent assessment, nab-PC demonstrated a significantly higher ORR than sb-PC (33% v 25%; response rate ratio, 1.313; 95% CI, 1.082 to 1.593; P = .005) and in patients with squamous histology (41% v 24%; response rate ratio, 1.680; 95% CI, 1.271 to 2.221; P < .001). nab-PC was as effective as sb-PC in patients with nonsquamous histology (ORR, 26% v 25%; P = .808). There was an approximately 10% improvement in progression-free survival (median, 6.3 v 5.8 months; hazard ratio [HR], 0.902; 95% CI, 0.767 to 1.060; P = .214) and overall survival (OS; median, 12.1 v 11.2 months; HR, 0.922; 95% CI, 0.797 to 1.066; P = .271) in the nab-PC arm versus the sb-PC arm, respectively. Patients ≥ 70 years old and those enrolled in North America showed a significantly increased OS with nab-PC versus sb-PC. Significantly less grade ≥ 3 neuropathy, neutropenia, arthralgia, and myalgia occurred in the nab-PC arm, and less thrombocytopenia and anemia occurred in the sb-PC arm. Conclusion The administration of nab-PC as first-line therapy in patients with advanced NSCLC was efficacious and resulted in a significantly improved ORR versus sb-PC, achieving the primary end point. nab-PC produced less neuropathy than sb-PC.

scholarly journals Phase II Study of WEE1 Inhibitor AZD1775 Plus Carboplatin in Patients With TP53-Mutated Ovarian Cancer Refractory or Resistant to First-Line Therapy Within 3 Months

2016 ◽  
Vol 34 (36) ◽  
pp. 4354-4361 ◽  
Author(s):  
Suzanne Leijen ◽  
Robin M.J.M. van Geel ◽  
Gabe S. Sonke ◽  
Daphne de Jong ◽  
Efraim H. Rosenberg ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Adverse Events ◽  
Phase Ii ◽  
Overall Response Rate ◽  
Response Rate ◽  
Phase Ii Study ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

Purpose AZD1775 is a first-in-class, potent, and selective inhibitor of WEE1 with proof of chemopotentiation in p53-deficient tumors in preclinical models. In a phase I study, the maximum tolerated dose of AZD1775 in combination with carboplatin demonstrated target engagement. We conducted a proof-of-principle phase II study in patients with p53 tumor suppressor gene ( TP53)–mutated ovarian cancer refractory or resistant (< 3 months) to first-line platinum-based therapy to determine overall response rate, progression-free and overall survival, pharmacokinetics, and modulation of phosphorylated cyclin-dependent kinase (CDK1) in skin biopsies. Patients and Methods Patients were treated with carboplatin (area under the curve, 5 mg/mL⋅min) combined with AZD1775 225 mg orally twice daily over 2.5 days every 21-day cycle until disease progression. Results AZD1775 plus carboplatin demonstrated manageable toxicity; fatigue (87%), nausea (78%), thrombocytopenia (70%), diarrhea (70%), and vomiting (48%) were the most common adverse events. The most frequent grade 3 or 4 adverse events were thrombocytopenia (48%) and neutropenia (37%). Of 24 patients enrolled, 21 patients were evaluable for efficacy end points. The overall response rate was 43% (95% CI, 22% to 66%), including one patient (5%) with a prolonged complete response. Median progression-free and overall survival times were 5.3 months (95% CI, 2.3 to 9.0 months) and 12.6 months (95% CI, 4.9 to 19.7), respectively, with two patients with ongoing response for more than 31 and 42 months at data cutoff. Conclusion To our knowledge, this is the first report providing clinical proof that AZD1775 enhances carboplatin efficacy in TP53-mutated tumors. The encouraging antitumor activity observed in patients with TP53-mutated ovarian cancer who were refractory or resistant (< 3 months) to first-line therapy warrants further development.

Treatment of carcinoma in situ of the glans penis with topical chemotherapy agents.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15100-e15100
Author(s):  
Hussain M Alnajjar ◽  
Wayne Lam ◽  
Marco Bolgeri ◽  
Rowland Rees ◽  
Matthew Perry ◽  
...  
Keyword(s):  
Adverse Events ◽  
Response Rate ◽  
Complete Response ◽  
First Line ◽  
End Points ◽  
First Line Therapy ◽  
Line Therapy ◽  
Local Toxicity ◽  
Chemotherapy Agents ◽  
Topical Chemotherapy

e15100 Background: To establish the response rate of 5-flurouracil (5-FU) and imiquimod (IQ) in the treatment of penile CIS in a large contemporary series in a supra-network center. The use of topical agents in the treatment of CIS of the penis has been well described in the literature. Previous studies have been limited by small sample size and imprecise end-points. Methods: Retrospective review of all primary and recurrent cases of penile CIS treated with 5-FU and IQ identified from a prospective database over a 10- year period. Therapy was standardised in all cases with application to the lesion for 12 hours every 48 hours for 28 days. 5-FU was the first line therapy and IQ used as second line topical agent. The primary end-point was defined as complete response (CR = resolution of lesion), partial response (PR = lesion reduced in size and or visibility) or no response (NR = no improvement in lesion size and or visibility). The secondary end-points included local toxicity and adverse events. Results: A total of 86 patients were diagnosed with CIS of the penis over the 10-year period. 44/86 (51%) received topical chemotherapy. Mean follow-up was 34 months. The response rates, local toxicity and adverse events were analysed. The overall complete response rate for topical agents was 57% (Table). Conclusions: Topical chemotherapy agents are moderately effective first line therapy in the treatment of penile CIS. Toxicity and adverse events were low with our treatment protocol. The issue of long-term surveillance and assessment of partial responders remains a challenge. Topical chemotherapy should remain a first line treatment option for penile CIS. [Table: see text]

Observational study of first-line therapy, including cetuximab in cases of nonresectable colorectal cancer: CORAL (interim report).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 681-681
Author(s):  
Hiroki Hashida ◽  
Kei Muro ◽  
Michio Itabashi ◽  
Yasuo Ohashi ◽  
Kenichi Sugihara
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Response Rate ◽  
Previous History ◽  
Efficacy And Safety ◽  
First Line ◽  
Treatment Results ◽  
First Line Therapy ◽  
Line Therapy ◽  
Skin Conditions

681 Background: Cetuximab (Cmab) + chemotherapy is now indicated in various treatment guidelines as a first-line therapy for non-resectable metastatic colorectal cancer (mCRC). The efficacy of Cmab + FOLFIRI has been demonstrated in CRYSTAL, but its efficacy and safety in combination with other regimens is unclear. There are few reports on Cmab combination therapy as first-line chemotherapy in Japan, and there are no reports of treatment results in the ESMO guideline groups 1, 2, and 3. Therefore an observational study was planned to evaluate the efficacy and safety of first-line therapy including Cmab, and to clarify the treatment results by group. This study received support from the Public Health Research Foundation’s Comprehensive Support Project for Oncology Research (CSPOR). Methods: The subjects were mCRC patients who received Cmab as first-line therapy either as combination therapy or monotherapy. Endpoints were response rate, PFS, and reason for discontinuation of first-line treatment (curative resection, PD, adverse events). To evaluate safety, skin conditions (incidence, degree, previous history) and other adverse events were investigated. Results: Among 579 patients enrolled at 158 institutes from January 2012 until June 2013, 575 were subjected to analysis. Background factors were PS 0/1/2 at 406/143/26, males females at 368/207, median age of 65 (31-88), groups 1/2/3 at 172/229/174, and concomitant drugs were oxaliplatin/irinotecan/others at 377/173/25. Response rate in the evaluable cases was 57%, and in groups 1/2/3 was 65%/54%/53%. The 1-year survival rate in groups 1/2/3 was 93%/61%/78%. In adverse events, the incidence of skin conditions (rash acneform) at 8 weeks/16 weeks was 69%/60% in patients with no history of acne vulgaris (2%/8% at G3 or higher) and 83%/81% in those with a previous history (13%/14% at G3 or higher). Conclusions: We reported treatment results according to ESMO guideline groups on the efficacy and safety of Cmab as first-line therapy in mCRC patients. Response rate and survival were higher in group 1. Survival outcomes after 1 year will be followed up. Clinical trial information: UMIN000007275.

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