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  • 1
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    P20-2 Observational study to evaluate RAS status in ctDNA for mCRC patients with RAS mutant tumor: RASMEX study (JACCRO CC-17)
    Elsevier BV ; 2022
    In:  Annals of Oncology Vol. 33 ( 2022-07), p. S519-
    Details
    In: Annals of Oncology, Elsevier BV, Vol. 33 ( 2022-07), p. S519-
    Type of Medium: Online Resource
    ISSN: 0923-7534
    URL: Article
    DOI: 10.1016/j.annonc.2022.05.257
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
    detail.hit.zdb_id: 2003498-2
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  • 2
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    Phase II study of panitumumab monotherapy in chemotherapy-naïve frail or elderly patients with unresectable, RAS wild-type colorectal cancer: OGSG 1602.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 4_suppl ( 2020-02-01), p. 106-106
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 4_suppl ( 2020-02-01), p. 106-106
    Abstract: 106 Background: Single agent of panitumumab (Pmab) is expected to be well tolerated and to improve survival in first-line setting in patients (pts) who are not eligible for intensive chemotherapy, although the efficacy and safety of Pmab for chemotherapy-naïve frail or elderly Japanese pts with wild-type (wt) RAS unresectable colorectal cancer (CRC) have not been yet studied. Methods: We conducted a multi-center phase II study. Pts aged over 76 years, or over 65 who were considered unsuitable for intensive chemotherapy. Pmab 6 mg/kg was administered intravenously every 2 weeks. The primary endpoint was disease control rate (DCR), and secondary endpoints included progression-free survival (PFS), overall survival (OS), response rate (RR), time to treatment failure (TTF), and the incidence of grade 3 or 4 toxicities. Sample size was set to 36 with exact p-value of 0.05, a power of 0.90, the null of hypothesis of 45% and alternative hypothesis of 70% based on the Clopper-Pearson method. Results: A total 36 pts were enrolled in February 2017 to August 2018. Two pts were excluded; one was a lack of image examination at baseline, and the other was a lack of measurable lesion. The median age was 81 (67-88), with 29 pts (85%) being aged over 76 years. There were 33 (92%) pts with performance status (PS) 0/1, while two (6%) and one (3%) pts were PS 2/3, respectively. Twenty-eight pts (78%) had left-sided CRC, while eight pts had right-sided CRC. The RR was 50.0% (95%CI, 32.4-67.6) including three cases (8.8%) of complete response, and SD was 26.5%, yielding 76.5% of DCR (p 〈 0.001, 90% confidence interval [CI], 61.5-87.7). The RR with left sided tumor was 65% (95%CI, 44.3-82.8), while that pts with right-sided tumor was 0% (95%CI, 0.0-36.9)(p = 0.003). The major grade 3 or 4 nonhematologic toxicities were rash (n = 6, 17%), hypomagnesemia (n = 4, 11%), fatigue (n = 3, 8%), paronychia (n = 3, 6%), and hyponatremia (n = 3, 6%). The grade 3 hematologic toxicities was neutropenia (n = 1, 3%). Conclusions: Pmab monotherapy showed the favolable efficacy and feasibility in the frail or elderly pts with RAS wt, unresectable CRC. The survival analysis including OS, PFS and TTF is awaiting. Clinical trial information: UMIN000024528.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.4_suppl.106
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
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  • 3
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    Safety and efficacy of panitumumab in combination with trifluridine/tipiracil for pre-treated patients with unresectable, metastatic colorectal cancer with wild-type RAS: The phase 1/2 APOLLON study
    Springer Science and Business Media LLC ; 2021
    In:  International Journal of Clinical Oncology Vol. 26, No. 7 ( 2021-07), p. 1238-1247
    Details
    In: International Journal of Clinical Oncology, Springer Science and Business Media LLC, Vol. 26, No. 7 ( 2021-07), p. 1238-1247
    Abstract: We aimed to assess the safety and efficacy of combination treatment with panitumumab plus trifluridine/tipiracil (FTD/TPI) in patients with wild-type RAS metastatic colorectal cancer (mCRC) who were refractory/intolerant to standard therapies other than anti-epidermal growth factor receptor therapy. Methods APOLLON was an open-label, multicentre, phase 1/2 trial. In the phase 1 part, 3 + 3 de-escalation design was used to investigate the recommended phase 2 dose (RP2D); all patients in the phase 2 part received the RP2D. The primary endpoint was investigator-assessed progression-free survival (PFS) rate at 6 months. Secondary endpoints included PFS, overall survival (OS), overall response rate (ORR), disease control rate (DCR), time to treatment failure (TTF), and safety. Results Fifty-six patients were enrolled (phase 1, n  = 7; phase 2, n  = 49) at 25 Japanese centres. No dose-limiting toxicities were observed in patients receiving panitumumab (6 mg/kg every 2 weeks) plus FTD/TPI (35 mg/m 2 twice daily; days 1–5 and 8–12 in a 28-day cycle), which became RP2D. PFS rate at 6 months was 33.3% (90% confidence interval [CI] 22.8–45.3). Median PFS, OS, ORR, DCR, and TTF were 5.8 months (95% CI 4.5–6.5), 14.1 months (95% CI 12.2–19.3), 37.0% (95% CI 24.3–51.3), 81.5% (95% CI 68.6–90.8), and 5.8 months (95% CI 4.29–6.21), respectively. Neutrophil count decreased (47.3%) was the most common Grade 3/4 treatment-emergent adverse event. No treatment-related deaths occurred. Conclusion Panitumumab plus FTD/TPI exhibited favourable anti-tumour activity with a manageable safety profile and may be a therapeutic option for pre-treated mCRC patients.
    Type of Medium: Online Resource
    ISSN: 1341-9625 , 1437-7772
    URL: Article
    DOI: 10.1007/s10147-021-01902-2
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 1481773-1
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  • 4
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    Neo RAS wild-type metastatic colorectal cancer in the SCRUM-Japan GOZILA study.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 3506-3506
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 3506-3506
    Abstract: 3506 Background: The ’’Neo RAS’’ phenomenon refers to RAS mutant (MT) metastatic colorectal cancer (mCRC) that becomes RAS wild-type (WT) following treatment. This Neo RAS WT population might represent a novel indication for EGFR inhibitors, which are less effective in RAS MT mCRC. The incidence and clinicopathological characteristics of Neo RAS WT mCRC using plasma cell-free DNA (cfDNA) next generation sequencing has not been defined. Methods: As part of a large-scale nationwide screening platform (SCRUM-Japan GOZILA), 478 patients with an initial diagnosis of RAS MT mCRC by tissue analysis (MEBGEN RASKET-B) who received systemic therapy underwent cfDNA testing (Guardant 360) prior to later lines of treatment. Based on the cfDNA results, we evaluated the clinicopathological characteristics of those with Neo RAS WT and RAS MT. Neo RAS WT was defined as no RAS MT ( KRAS or NRAS) detected in plasma and was assessed in the overall cohort (Cohort A) and in the subgroup with at least one somatic alteration detected in plasma (Cohort B) to exclude those with insufficient tumor DNA shedding. Results: Median age at the time of blood sampling was 62.0 years old, and 257 (51.9%) were men. 160 (32.3%) and 319 (64.4%) had right-sided tumors and multi-organ metastases. The lungs were the most frequent site of metastasis (60.2%), followed by liver (57.4%), lymph nodes (28.9%), and peritoneum (28.5%). The prevalence of Neo RAS WT was 19.0% (91/478) in Cohort A and 9.8% (41/429) in Cohort B. The frequency of Neo RAS WT in tumors originally with KRAS exon 2 MT tended to be lower than in those with other RAS MT (18.1% vs 25.4%, P = 0.21 in Cohort A, 9.0% vs 15.4%, P = 0.14 in Cohort B). There were significant differences in the prevalence of Neo RAS WT between patients with single organ vs multi-organ metastases (P 〈 0.001 in Cohort A, P = 0.004 in Cohort B), absence vs presence of liver metastasis (P 〈 0.001 in both Cohort A and B), lymph node metastasis (P = 0.006 in Cohort A), peritoneal metastasis (P = 0.002 in group A), and bone metastasis (P = 0.029 in Cohort A), testing immediately prior to 2 nd through to 4 th line treatment vs later lines (P = 0.007 in Cohort A), immediate prior use of regorafenib (P = 0.027 in Cohort A) and any history of vascular endothelial growth factor inhibitors (P = 0.003 in Cohort A, P = 0.035 in Cohort B). In the logistic regression multivariate analysis, absence of liver metastasis (odds ratio [OR], 5.83; P 〈 0.001 in Cohort A, OR, 2.84; P = 0.005 in Cohort B), absence of lymph node metastasis (OR, 2.18; P = 0.034 in Cohort A) and tissue RAS MT other than KRAS exon 2 (OR, 2.35; P = 0.049 in Cohort B) were significantly related to the emergence of Neo RAS WT. Among 6 Neo RAS WT patients tretd with EGFR inhibitors, one had partial response and another one had stable disease for at least 6 months. Conclusions: Liver and lymph node metastasis and RAS MT other than those in KRAS exon 2 are factors associated with the development of Neo RAS WT mCRC. EGFR inhibitors might be effective treatment.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.3506
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
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  • 5
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    The Phase II Study of Panitumumab in Chemotherapy-Naïve Frail or Elderly Patients with RAS Wild-type Colorectal Cancer: OGSG 1602 Final Results
    Oxford University Press (OUP) ; 2023
    In:  The Oncologist Vol. 28, No. 7 ( 2023-07-05), p. e565-e574
    Details
    In: The Oncologist, Oxford University Press (OUP), Vol. 28, No. 7 ( 2023-07-05), p. e565-e574
    Abstract: We previously reported the response rate of a phase II OGSG1602 study on panitumumab in chemotherapy-naive frail or elderly patients with RAS wild-type unresectable colorectal cancer (CRC) [Terazawa T, Kato T, Goto M, et al. Oncologist. 2021;26(1):17]. Herein, we report a survival analysis. Methods Patients aged ≥65 years and considered unsuitable for intensive chemotherapy or aged ≥76 years were enrolled. Primary tumors located from the cecum to the transverse colon were considered right-sided tumors (RSTs); those located from the splenic flexure to the rectum were considered left-sided tumors (LSTs). Results Among the 36 enrolled patients, 34 were included in the efficacy analysis, with 26 and 8 having LSTs and RSTs, respectively. The median progression-free survival (PFS) and overall survival (OS) were 6.0 [95% CI, 5.4-10.0] and 17.5 months (95% CI, 13.8-24.3), respectively. Although no significant differences existed in PFS between patients with LST and RST {6.6 (95% CI, 5.4-11.5) vs. 4.9 months [95% CI, 1.9-not available (NA), P = .120] }, there were significant differences in OS [19.3 (95% CI, 14.2-NA) vs.12.3 months (95% CI, 9.9-NA), P = .043]. Conclusion Panitumumab showed favorable OS in frail or elderly patients with RAS wild-type CRC and no prior exposure to chemotherapy. Panitumumab may be optimal for patients with LSTs (UMIN Clinical Trials Registry Number UMIN000024528).
    Type of Medium: Online Resource
    ISSN: 1083-7159 , 1549-490X
    URL: Article
    DOI: 10.1093/oncolo/oyac145
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
    detail.hit.zdb_id: 2023829-0
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  • 6
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    Phase II Study of Panitumumab Monotherapy in Chemotherapy-Naïve Frail or Elderly Patients with Unresectable RAS Wild-Type Colorectal Cancer: OGSG 1602
    Oxford University Press (OUP) ; 2021
    In:  The Oncologist Vol. 26, No. 1 ( 2021-01-01), p. 17-e47
    Details
    In: The Oncologist, Oxford University Press (OUP), Vol. 26, No. 1 ( 2021-01-01), p. 17-e47
    Abstract: Panitumumab monotherapy showed favorable efficacy and feasibility in the treatment of frail or elderly patients with RAS wild-type unresectable colorectal cancer. It is especially effective for left-sided tumors; therefore, panitumumab as first-line treatment could be an additional therapeutic option for frail elderly patients, particularly in those who are unsuitable for upfront oxaliplatin-based or irinotecan-based combination regimens. Background First-line panitumumab monotherapy is expected to be well tolerated and improve survival in patients ineligible for intensive chemotherapy. However, its safety and efficacy in chemotherapy-naïve frail or elderly patients with unresectable RAS wild-type (WT) colorectal cancer (CRC) have not been studied. The aim of this phase II trial was to evaluate the efficacy and safety of panitumumab as first-line treatment. Methods We conducted a multicenter phase II study on patients aged ≥76 years or ≥65 years considered unsuitable for intensive chemotherapy. Panitumumab 6 mg/kg of intravenous infusion was administered every 2 weeks. The primary endpoint was disease control rate (DCR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), response rate (RR), time to treatment failure (TTF), and incidence of grade 3 or 4 toxicities. Results Thirty-six patients (median age: 81 [range, 67–88] years) were enrolled between February 2017 and August 2018. Two patients were excluded from the analysis of efficacy: one from lack of image examination at baseline and the other from lack of a measurable lesion. Thirty-three (91.6%) patients had a performance status (PS) of 0 or 1, whereas two (5.6%) patients and one (2.8%) patient had a PS of 2 and 3, respectively. Twenty-eight patients (77.8%) had left-sided CRC, whereas eight (22.2%) had right-sided CRC. The RR was 50.0% (95% confidence interval [CI] , 32.4–67.6), including three patients (8.8%) who had complete responses. A total of 26.5% had stable diseases, resulting in a DCR of 76.5% (90% CI, 61.5–87.7). The RR of patients with left- and right-sided tumors was 65.4% (95% CI, 44.3–82.8) and 0.0% (95% CI, 0.0–36.9), respectively. Major grade 3 or 4 nonhematologic toxicities were rash (n = 6, 16.7%), hypomagnesemia (n = 4, 11.1%), fatigue (n = 3, 8.3%), paronychia (n = 2, 5.6%), and hyponatremia (n = 2, 5.6%). The only grade 3 hematologic toxicity was neutropenia (n = 1, 2.8%). Conclusion Panitumumab monotherapy showed favorable efficacy and feasibility in frail or elderly patients with RAS WT unresectable CRC. Survival analysis including OS, PFS, and TTF is currently in progress.
    Type of Medium: Online Resource
    ISSN: 1083-7159 , 1549-490X
    URL: Article
    DOI: 10.1002/ONCO.13523
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 7
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    An observational study to evaluate RAS mutations in circulating tumor DNA after standard chemotherapies for metastatic colorectal cancer patients with tumors harboring RAS mutation: RASMEX study (JACCRO CC-17).
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 4_suppl ( 2022-02-01), p. TPS230-TPS230
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 4_suppl ( 2022-02-01), p. TPS230-TPS230
    Abstract: TPS230 Background: RAS status in tumor tissue is a predictive factor for the efficacy of anti-epidermal growth factor receptor (EGFR) antibodies therapy in patients (pts) with metastatic colorectal cancer (mCRC). In mCRC pts with tumors harboring RAS mutation, anti-EGFR antibodies therapy has the lack of clinical benefit; thus, the survival of RAS mutant mCRC pts is shorter compared to RAS wild mCRC pts. Recently, several studies have shown that colorectal cancer tissue had heterogeneity of gene profiling, and the analysis of circulating tumor DNA (ctDNA) in blood samples could detect the change of gene alterations in tumors which were caused by chemotherapy. Bouchahda et al., demonstrated that nearly half of the pts with RAS mutant mCRC had no detectable RAS mutation in ctDNA after first-line chemotherapy; moreover, some of the pts had clinical benefits from post-anti-EGFR antibodies therapy. Therefore, anti-EGFR antibodies therapy might become a novel treatment option for RAS mutant mCRC pts without RAS mutations in ctDNA after chemotherapies. Other report also showed the frequency of no RAS mutations in ctDNA was about 1%. There have been few studies to prospectively evaluate the RAS status in ctDNA for mCRC pts with RAS mutant tumors treated with standard chemotherapies. We, therefore, conducted an observational study to evaluate RAS mutations and the mutation allele frequency in ctDNA for mCRC pts with RAS mutant tumors who were treated with first- or second-line chemotherapy. Methods: This study is a multi-center observational/translational study in 67 facilities. The key eligibility criteria are as follows: 1) Eastern Cooperative Oncology Group Performance status 0-1, 2) histologically proven unresectable mCRC, 3) RAS mutation in tumor tissue, 4) refractory or intolerable after response to prior fluoropyrimidine-containing regimen. OncoBEAM RAS CRC kit is used to investigate RAS status in ctDNA just after first- or second-line treatment in enrolled pts. The primary endpoint is the frequency of pts without RAS mutations in ctDNA. Secondary endpoints include mutation allele frequency of RAS in ctDNA and clinical outcomes of pre- and post-treatments (overall response rate, disease control rate, overall survival, and progression-free survival). As the exploratory analysis, gene alterations related to the resistant mechanism of anti-EGFR antibodies (BRAF, PIK3CA, ERBB2, MET) are analyzed in pts without RAS mutations in ctDNA. We assume that no RAS mutations are observed in ctDNA in at least 1 % pts. We expect that one patient with no RAS mutations in ctDNA is detected in 100 pts; thus, the sample size of 300 pts is set for our study. Accrual is starting in April 2021. Clinical trial information: UMIN000043442.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.4_suppl.TPS230
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 8
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    Phase II study of panitumumab monotherapy in chemotherapy-naïve frail or elderly patients with unresectable, RAS wild type colorectal cancer: OGSG 1602, survival update data.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 3558-3558
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 3558-3558
    Abstract: 3558 Background: We previously reported the result of the phase II OGSG1602 study in which single agent of panitumumab (Pmab) demonstrated 76.5% and 50% of disease control rate (DCR), primary endpoint, and response rate (RR), respectively, in chemotherapy-naïve frail or elderly patietns (pts) with wild-type (wt) RAS unresectable colorectal cancer (CRC). Here, we reports the survival analysis including overall survival (OS) and progression free survival (PFS) in terms of sidedness and early tumor shrinkage (ETS). Methods: Thirty-six pts aged ≥76 years, or ≥65 considered unsuitable for intensive chemotherapy were enrolled and received Pmab 6 mg/kg intravenously every 2 weeks. Primary tumors located in the cecum to transverse colon were coded as right-sided tumors (RST), while tumors located from the splenic flexure to rectum were considered left-sided tumors (LST). Early tumor shrinkage (ETS) was determined as tumor reduction of 20% at week 8 compared to baseline. Results: Of total of 36 enrolled pts, 34 pts were included in the efficacy analysis, with pts with LST vs. RST being 26 vs. 8 cases, while pts who achieved ETS (ETS+) vs. those who did not achieve ETS (ETS-) being 15 vs. 19 cases. Among the evaluable 34 pts, the median PFS (mPFS) and median OS (mOS) were 6.0 months (95% Confidence Interval [CI] : 5.4-10.0) and 17.5 months (95%CI, 13.8-24.3), respectively, with the median follow-up of 17.0 months. For PFS, there were no significant differences between pts with LST vs. RST [6.6 months (95%CI, 5.4-11.5) vs. 4.9 months (95%CI, 1.9-NA), p = 0.120] but between pts with ETS+ vs. ETS- [10.4 months (95%CI, 7.4-NA) vs. months (95%CI, 2.1-7.9), p = 0.001] . Furthermore, OS was significantly different either in pts with LST vs. RST [19.3 months (95%CI, 14.2-NA) vs. 12.3 (95%CI, 9.9-NA), p = 0.043] or in pts with ETS+ vs. ETS- [ months (n = 15, 95%CI, 19.6-NA) vs. 10.1 months (n = 19, 95%CI, 6.8-21.8), p 〈 0.001]. Conclusions: Pmab monotherapy showed the favolable OS in the frail or elderly pts with RAS wt, unresectable CRC. Our data also confirmed the prognostic value of sidedness as well as predictive value of ETS in this setting. Clinical trial information: UMIN000024528. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.3558
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
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