GLORIA

GEOMAR Library Ocean Research Information Access

X

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
  • 1
    Online Resource
    Online Resource
    A randomized phase II/III trial comparing hepatectomy followed by mFOLFOX6 with hepatectomy alone for liver metastasis from colorectal cancer: JCOG0603 study.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 4005-4005
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 4005-4005
    Abstract: 4005 Background: The role of adjuvant chemotherapy after hepatectomy is controversial for liver only metastases from colorectal cancer (LM). Current recommendations for oxaliplatin-containing adjuvant regimen (FOLFOX) for LM are based on extrapolation of the results of the EORTC intergroup trial 40983, which showed that perioperative FOLFOX confirmed a progression-free survival benefit but did not affect overall survival (OS) in LM patients. We conducted a randomized controlled trial to determine if adjuvant modified FOLFOX (mFOLFOX) is superior to hepatectomy alone for LM. Methods: Eligible patients aged 20-75 years who had histologically proven colorectal adenocarcinoma with an unlimited number of LM were randomly assigned (1:1) to receive either adjuvant mFOLFOX6 (oxaliplatin 85mg/m 2 , l-LV 200 mg/m 2 , 5-FU bolus 400 mg/m 2 and 2400mg/m 2 over 48 h), for 12 cycles after surgery (CTX arm), or surgery alone (S alone arm). When treatment compliance after 9 courses of CTX was as high as expected in phase II, the registration was continued in phase III. The primary endpoint of phase III was disease-free survival (DFS), and the secondary endpoints were OS, toxicity, and sites of relapse. The planned sample size was 150 patients (pts) per arm, with a one-sided alpha of 5%, and 80% power detecting a 5y-DFS difference of 12% (25% with S alone vs. 37% with CTX). Results: Between Mar. 2007 and Jan. 2019, 300 patients were randomized. 151 pts were allocated to CTX, and 149 pts to S alone. When the third interim analysis of phase III was performed in Dec. 2019, the DSMC recommended the early termination of the trial because a statistically significant difference in terms of DFS but the futility in terms of OS was found. With a median follow-up period of 54 months for disease-free surviving patients, the 3y-DFS was 52.1% (95% CI 43.2 – 60.2) with CTX and 41.5% (33.2 – 49.6) with S alone (hazard ratio 0.63 [0.45 – 0.89], one-sided p = 0.002 〈 0.0163 for the one-sided alpha level at the interim analysis). However, the 3y-OS was 86.6% (79.2-91.4) with CTX and 92.2% (86.0 – 95.8) with S alone (hazard ratio 1.35 [0.84 – 2.19]). The 5y-OS was 69.5% (59.6-77.5) with CTX and 83.0% (74.5-88.9) with S alone. Median OS after recurrence was 38.4 months in the CTX arm and 87.6 in the S alone arm. Conclusions: DFS did not correlate with OS for LM. Postoperative chemotherapy with mFOLFOX6 improves DFS but worsens OS over surgery alone due to more deaths after recurrence in the CTX arm. Adjuvant mFOLFOX is not beneficial to patients after hepatectomy for LM. Clinical trial information: UMIN000000653 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.4005
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 2
    Online Resource
    Online Resource
    Real-world outcomes of Asian patients with advanced BRAF-mutant melanoma treated with first-line BRAF/MEK inhibitors, anti-PD-1 monotherapy, or combination of nivolumab plus ipilimumab: A multicenter retrospective study in Japan (B-CHECK-RWD study).
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. e21553-e21553
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e21553-e21553
    Abstract: e21553 Background: The systemic treatment for advanced BRAF-mutant melanoma includes BRAF/MEK inhibitors (BRAF/MEKi), anti-PD-1 monotherapy (aPD1), and the combination of nivolumab plus ipilimumab (NIVO/IPI). Several studies have demonstrated favorable survival benefits for those treated with immunotherapy upfront. Most of these studies, however, were conducted among Caucasian-dominant cohorts; evidence for Asian patients is limited. Therefore, our objective was to assess the efficacy of first-line therapies for Asian patients in a real-world setting. Methods: We retrospectively collected the clinical data of Asian patients with advanced BRAF-mutant melanoma treated with first-line BRAF/MEKi, aPD1, or NIVO/IPI from 26 institutions in Japan. Clinical outcomes were determined by assessing the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) by first-line therapies. Kaplan‐Meier curves and log‐rank tests, as well as multivariable Cox proportional hazard models were used to estimate survival probabilities. Results: We identified 316 Asian patients treated with first-line BRAF/MEKi (n = 224), aPD1 (n = 59), or NIVO/IPI (n = 33) between 2016 and 2021. At baseline, the median age of the patients in each treatment arm was 63, 62, and 54, respectively (p = 0.053). The ORR in the first-line therapy was 69%, 29%, and 27%, respectively (p 〈 0.001). With a median follow-up of 18.9 months, the median PFS was 16.2, 5.6, and 6.4 months (p = 0.001); and the median OS was 36.9, 37.9 months, and not reached (p = 0.386), respectively. In a multivariable analysis, the predictive factors of short PFS were first-line therapy with aPD1 (HR, 2.44; 95%CI, 1.70-3.50, p 〈 0.001) or NIVO/IPI (1.73; 1.06–2.83, p = 0.029), BRAF V600K (p = 0.031), ECOG PS ≥2 (p = 0.011), elevated lactate dehydrogenase (LDH) levels (p = 0.001), and M1a/M1c/M1d stages (p = 0.036/ 〈 0.001/ 〈 0.001, respectively). Predictive factors of short OS were BRAF V600K (p = 0.042), ECOG PS ≥2 (p = 0.001), elevated LDH levels (p 〈 0.001), and M1c/M1d stages (both p 〈 0.001). The OS did not differ significantly by first-line therapies between BRAF/MEKi, aPD1 (1.52; 0.98–2.34, p = 0.061), and NIVO/IPI (0.63; 0.31–1.27, p = 0.194). Conclusions: Although upfront NIVO/IPI showed the longest OS numerically, its superiority over BRAF/MEKi in Asian patients seems to be modest compared with Caucasian patients. Because upfront BRAF/MEKi showed an OS that was comparable with that of aPD1, BRAF/MEKi remains an active first-line therapy option, especially for those who are not amenable to take the high risk of immune-related toxicities.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.e21553
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 3
    Online Resource
    Online Resource
    Real-world efficacy of chemotherapy in patients with advanced extramammary Paget's disease: A retrospective, multicenter study of 204 Japanese patients.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. e21579-e21579
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e21579-e21579
    Abstract: e21579 Background: Extramammary Paget's disease (EMPD) is a rare skin cancer that develops in the vulva, anus, and axilla. The incidence rate of EMPD is 0.13 per 100,000 population/year in Caucasians and 0.28 in Asians; thus, it is more frequent in Asians. Although distant metastases have been reported to occur in 10%-20% of all cases of EMPD, standard systemic chemotherapy for advanced EMPD has not been established worldwide. Retrospective studies conducted thus far have been insufficient due to their small sample sizes. Furthermore, there are no reports comparing the effectiveness of multiple treatments. To establish a standard treatment for advanced EMPD, prospective clinical trials are necessary, and we are planning a prospective clinical trial. As a pilot study, we investigated a large sample of patients with advanced EMPD and analyzed the efficacy of systemic chemotherapies. Methods: Patients with advanced EMPD who were treated in 16 Japanese institutions during 2011-2022 were evaluated. The efficacy of each treatment was estimated by determining the objective response rate (ORR) or progression-free survival (PFS) and overall survival (OS) using the Kaplan-Meier analysis. Multivariable analysis was performed to account for potential confounding factors, such as age, sex, and performance status (PS). A total of 204 patients were enrolled, of which 164 (80.4%) patients were treated as follows: Docetaxel hydrate (DOC), n = 108 (52.9%); tegafur/ gimeracil/ oteracil potassium (S-1)/DOC, n = 16 (7.8%); fluorouracil/cisplatin (FP), n = 26 (12.8%); fluorouracil/epirubicin/carboplatin/vincristine/mitomycin C (FECOM), n = 3 (1.5%); and other, n = 11 (5.4%). Forty (19.6%) patients received the best supportive care. Results: OS and PFS did not differ significantly among the DOC, S-1/DOC, FP, FECOM, and other groups (p = 0.176 and p = 0.568, respectively). The ORRs in the S-1/DOC, DOC, FP, and FECOM groups were 75.0%, 51.9 %, 38.5%, and 66.7%, respectively. The odds ratio for the ORR of the S-1/DOC group compared with the DOC group estimated by the logistic regression analysis with adjustment for age, sex, and PS was 2.72, (95% CI: 1.09-6.78, p = 0.032). S-1/DOC was the only treatment with a significantly higher ORR than that of DOC, which is the most frequently used treatment for advanced EMPD in Japan. Conclusions: Although there were no significant differences in PFS and OS between the multiple regimens, the S-1/DOC group showed significantly higher ORR compared with the DOC group. Because the high response rate to S-1/DOC greatly improves the quality of life of patients with advanced EMPD, S-1/DOC may be more beneficial than DOC and other regimens for the treatment of advanced EMPD. A phase II clinical trial of S-1/DOC is currently planned in Japan.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.e21579
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 4
    Online Resource
    Online Resource
    Prognostic factors in locally advanced, unresectable esophageal cancer patients treated with chemoradiotherapy (exploratory analysis of JCOG0303).
    American Society of Clinical Oncology (ASCO) ; 2015
    In:  Journal of Clinical Oncology Vol. 33, No. 3_suppl ( 2015-01-20), p. 150-150
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 3_suppl ( 2015-01-20), p. 150-150
    Abstract: 150 Background: The prognosis of patients (pts) with locally advanced esophageal squamous cell carcinoma (LAESCC) is generally dismal. Definitive chemoradiotherapy (CRT) with cisplatin plus 5-fluorouracil (CF-RT) is the standard treatments especially for the pts with unresectable LAESCC. The aim of this study is to investigate the possible prognostic factors and predictive accuracy of the Glasgow Prognostic Score (GPS) in the pts with unresectable LAESCC treated with CRT. Methods: 142 patients were enrolled to JCOG0303, and assigned to standard CF-RT group and low-dose CF-RT group. 131 pts with sufficient data were used for this analysis. Cox regression model was used for an analysis of prognostic factors of the pts with unresectable LAESCC treated with CF-RT. GPS was classified by baseline CRP and serum albumin. Pts with a CRP ≤ 1.0 mg/dL and albumin ≥ 3.5 g/dL were allocated to GPS0 group. If only CRP was increased or albumin decreased,pts were allocated to the GPS1 and pts in whom CRP was 〉 1.0 mg/dL and albumin level 〈 3.5 g/dL were classified as GPS2. Results: The pts background was as follows: median age (range), 62 (37-75), male / female, 119/12; ECOG PS 0/1/2, 64/65/2; clinical stage (UICC 6th) IIB/III/IVA/IVB, 3/75/22/31. As a result of multivariable analysis including all variables, the factors which became statistically significant were shown in the table. In several sensitivity multivariate analyses, only esophageal stenosis was indicated as a common poor prognostic factor. In addition, overall survival tended to decrease according to GPS subgroups (median survival time(m): GPS0/GPS1/GPS2 16.1/14.9/8.7). Conclusions: Presence of stenosis was thought to be one of the candidates for stratification factor in randomized trial for unresectable LAESCC pts. Furthermore, GPS represents a prognostic fator in LAESCC pts treated with CRT. Clinical trial information: 000000861. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2015.33.3_suppl.150
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 5
    Online Resource
    Online Resource
    Effect of lymph node dissection and adjuvant therapy in patients with sentinel node+ melanoma: An observational multicenter study.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. e21569-e21569
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e21569-e21569
    Abstract: e21569 Background: Currently, lymph node dissection (LND) is not mandatory for patients with sentinel node (SN)+ melanoma. Anti-programmed cell death receptor-1 (PD-1) monotherapy and dabrafenib/trametinib combination (for BRAF mutations) are standard adjuvant treatments for patients who undergo definitive surgery for melanoma. However, the effects of this approach remain unclear in patients with stage III melanoma in real-world clinical settings. We investigated the effects of the aforementioned therapeutic approaches on the prognosis of stage III melanoma in a Japanese cohort. Methods: We retrospectively analyzed clinical data of patients with SN+ melanoma treated with or without anti-PD-1 monotherapy or combination dabrafenib/trametinib therapy obtained from 39 independent institutions in Japan between 2018 and 2021. Survival outcomes (recurrence-free survival [RFS] and overall survival [OS] ) were compared with regard to LND, adjuvant therapy type, and clinical factors. Results: We investigated 357 patients; 35.9% (128/357) of patients underwent LND, of whom 70.3% (90/128) received adjuvant therapy. LND was not performed in 64.1% (229/357) of patients, of whom 74.7% (171/229) received adjuvant therapy. RFS and OS did not differ between patients with and without LND (2-year RFS 54.5% vs. 51.5%, p = 0.98; 2-year OS 84.1% vs. 86.5%, p = 0.39). RFS and OS did not differ between patients with and without adjuvant therapy (2-year RFS 54.5% vs. 50.4%, p = 0.90; 2-year OS 83.4% vs. 89.8%, p = 0.33). Multivariate analysis of RFS after adjustment for adjuvant therapy, clinical subtype, tumor thickness, ulceration, and BRAF status showed significant differences between patients with and without adjuvant therapy (hazard ratio 3.06 [95% confidence interval 1.39–6.76]). Data analysis in 261 patients who received adjuvant therapy showed no difference between patients with and without LND (2-year RFS 55.9% vs. 52.6%, p = 0.74; 2-year OS 83.4% vs. 83.6%, p = 0.73). Regarding adjuvant therapy type, RFS and OS were significantly longer in patients who received BRAF/MEK inhibitors than in those treated with PD-1 monotherapy (2-year RFS 75.0% vs. 42.2%, p 〈 0.01; 2-year OS 89.3% vs. 79.5%, p = 0.01). Conclusions: Our study revealed that LND did not affect prognosis and adjuvant therapy reduced the recurrence of stage III melanoma in a Japanese cohort. Although the follow-up period was short, with regard to drug selection, RFS and OS were significantly longer in patients treated with BRAF/MEK inhibitors than in those who received PD-1 monotherapy. Factors contributing to the lower effectiveness of PD-1 monotherapy remain unclear and warrant further investigation.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.e21569
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 6
    Online Resource
    Online Resource
    Comparison of the long-term toxicities conferred by two different doses of definitive chemoradiotherapy for stage II/III esophageal squamous cell carcinoma.
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Clinical Oncology Vol. 32, No. 3_suppl ( 2014-01-20), p. 96-96
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 3_suppl ( 2014-01-20), p. 96-96
    Abstract: 96 Background: Definitive chemoradiotherapy is one of the options for stage II/III esophagealsquamous cell carcinoma (ESCC). RTOG9405 recently reported that a higher dose of radiation did not confer any additional survival benefit over the standard dose (50.4 Gy). We comparedthe long-term toxicities conferred by chemoradiation at a dose of 60 Gy and 50.4 Gy for stage II/III ESCC. Methods: Eligibility criteria included clinical stage II/III (non-T4) (UICC-TNM, 6 th edition) ESCC, performance status 0-2, and age 20-75 years. The study group comprised 254 patients who received definitive chemoradiotherapy as first-line therapy between January 2000 and August 2010 in our hospital. Group J (n=207) received 2 cycles of cisplatin (40 mg/m 2 on days 1 and 8) with fluorouracil infusion (400 mg/m 2 /day on days 1-5 and 8-12), or 2 cycles of cisplatin(70 mg/m 2 on day 1) with fluorouracil infusion (700 mg/m 2 /day on days 1-4) and concurrent radiotherapy at 60 Gy. Group R (n = 47) received 2 cycles of cisplatin (75 mg/m 2 on day 1) with fluorouracil infusion (1000 mg/m 2 /day on days 1–4) and concurrent radiotherapy at 50.4 Gy. Long-term toxicity was evaluated according to the Common Terminology Criteria for Adverse Event Ver. 3.0. Results: The characteristics of both groups are as follows (J:R group): median age, 64:63; male/female, 178/29:42/5; PS 0/1/2, 90/104/1:33/14/0; stage IIA/IIB/III: 48/58/101:6/20/21. The median follow-up period was more than 60 months for both groups, with 5-year survival rates of 43.6% and 58.6% for the J and R group, respectively. The proportion of patients with grade 3/4 long-term toxicity in each group was as follows (J/R group): pleural effusion, (8.7%/0%; p = 0.036); pericardial effusion, (6.7%/2.1%; p = 0.196); radiation pneumonitis, (2.4%/4.2%); esophagitis, (0.9%/0%); and pericarditis, (2.4%/0%). Grade 3/4 late toxicity was observed more frequently in the J group (15.0%) than in the R group (6.4%) (p = 0.087). Treatment-related death due to pneumonitis was observed in only 1 patient in group J. Conclusions: The RTOG regimen at a dose of 50.4 Gy showed promising results while inducing lower late toxicity rates than when administered at 60 Gy.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2014.32.3_suppl.96
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 7
    Online Resource
    Online Resource
    Postoperative XELOX therapy for patients with curatively resected high-risk stage II and stage III rectal cancer without preoperative chemoradiation: A prospective, multicenter, open-label, single arm phase II study.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e16039-e16039
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e16039-e16039
    Abstract: e16039 Background: Preoperative 5-FU-based chemoradiation is currently a standard treatment for advanced rectal cancer, particularly in Western countries. Although it reduced the local recurrence, it could not necessarily improve overall survival. Furthermore, it can also produce adverse effects and long-term sphincter function deficiency. Adjuvant oxaliplatin plus capecitabine (XELOX) is a recommended regimen for patients with curatively resected colon cancer. However, the efficacy of postoperative adjuvant therapy for rectal cancer patients who have not undergone preoperative chemoradiation remains unknown. We aimed to evaluate the efficacy of surgery and postoperative XELOX without preoperative chemoradiation for treating rectal cancer. Methods: We performed a prospective, multicenter, open-label, single arm phase II study. Patients with curatively resected high-risk stages II and III rectal cancer who had not undergone preoperative therapy were treated with a 120 min intravenous infusion of oxaliplatin (130 mg/m 2 ) on day 1 and capecitabine (2,000 mg/m 2 /day) in 2 divided doses for 14 days of a 3-week cycle, for a total of 8 cycles (24 weeks). The primary endpoint was 3-year disease-free survival (DFS). Results: Between August 2012 and June 2015, 60 men and 47 women with a median age was 63 years (range: 29–77 years) were enrolled. Ninety-three patients had Eastern Cooperative Oncology Group performance status scores of ‘0’ and 14 had scores of ‘1’. Tumors were located in the upper and lower rectums in 54 and 48 patients, respectively; 8 patients had stage II disease and 99 had stage III. The 3-year DFS was 70.1% (95% confidence interval, 60.8–78.0%) and 33 patients (31%) experienced recurrence, most commonly in the lung (16 patients) followed by local recurrence (9) and hepatic recurrence (7). Conclusions: Postoperative XELOX without preoperative chemoradiation is effective for rectal cancer and provides good 3-year DFS prospects.And this is probably the first and last report in the world for such cases. Trial registration: This clinical trial was registered in the University Hospital Medical Information Network registry system as UMIN000008634 at Aug 06, 2012.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e16039
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 8
    Online Resource
    Online Resource
    Impact of preoperative therapy for locally advanced thoracic esophageal cancer on the risk of perioperative complications: Results from multicenter phase III trial JCOG 1109.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 3_suppl ( 2021-01-20), p. 162-162
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 3_suppl ( 2021-01-20), p. 162-162
    Abstract: 162 Background: We have conducted randomized three-arm phase III trial comparing cisplatin plus 5-FU (CF) versus docetaxel plus CF (DCF) versus radiation with CF (CF-RT) as preoperative therapy for locally advanced esophageal cancer, which is on-follow-up for primary analysis planned in 2023 (JCOG 1109). This study aimed to evaluate the influence of preoperative therapies on perioperative complications and risk factors for perioperative complications after three-arm preoperative therapies. Methods: Patients with potentially resectable advanced thoracic esophageal cancer were randomly assigned to three preoperative therapies and followed by open or thoracoscopic esophagectomy with regional lymphadenectomy. Clinical data, surgical results, and perioperative complications in the patients received DCF and CF-RT were compared with those in the patients received CF. Univariate and multivariate analyses were performed to explore the risk factors of perioperative complications. Results: Between December 2012 and July 2018, 601 patients were randomized (CF/DCF/CF-RT; 199/202/200). Of 589 eligible patients, 546 patients underwent surgery (185/183/178). Patients` characteristics were not different between arms. Median number of harvested lymph node in patients received CF-RT was significantly lower than that in patients received CF (49 vs. 58; P 〈 0.0001). Incidence of ≥ Grade 2 perioperative complications in patients received DCF was lower than that in patients received CF (44.8% vs. 56.2%; P = 0.036). Incidence of ≥ Grade 2 chylothorax in patients received CF-RT was higher than that in patients received CF (5.1% vs. 1.1%; P = 0.032). Incidence of reoperation and intra-hospital death in patients received DCF and CF-RT did not differ from that in patients received CF. Multivariate analysis showed that operation time (≥ median) and open esophagectomy were independently associated with an increase in ≥ Grade 2 perioperative complications. CF-RT was associated with an increase in occurrence of ≥ Grade 2 chylothorax (Relative Risk 4.84; P = 0.043). Conclusions: Preoperative DCF and CF-RT does not increase the risk of perioperative complications and mortality when compared with standard preoperative CF therapy, but CF-RT increases the risk of chylothorax after esophagectomy for advanced thoracic esophageal cancer.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.3_suppl.162
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 9
    Online Resource
    Online Resource
    Phase II trial of perioperative chemotherapy of esophageal cancer: PIECE trial.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 4038-4038
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 4038-4038
    Abstract: 4038 Background: Neoadjuvant chemotherapy followed by surgery (NAC-S) is the standard therapy for locally advanced esophageal squamous cell cancer (ESCC) in Japan. The aim of this phase II trial was to assess the efficacy and safety of the addition of adjuvant S-1 after R0 resection in patients treated with NAC-S. Methods: Key eligibility criteria were as follows: ESCC of clinical stage IB-III (without T4 disease); aged 20 to 75 years; ECOG performance status 0 or 1; and performed neoadjuvant chemotherapy (5-FU + cisplatin). All patients registered before surgery. Patients received adjuvant therapy with 4 cycles of S-1 (80 mg/m 2 /day) that is administered orally for 4 weeks of a 6-weeks cycle. The primary endpoint was three-year relapse free survival (RFS). Results: A total of 52 patients were enrolled between January 2016 and January 2019. Two patients (one with small cell carcinoma and the other with synchronous malignancy) were excluded from analysis. Five patients were diagnosed as R1 or R2. Seven patients did not receive adjuvant S-1 due to adverse events of surgery in 5 patients, refusal to adjuvant S-1 in a patient, and forgot to start in a patient. Thirty-eight patients received adjuvant S-1, with 32 patients completing 4 cycles. The median relative dose intensity of adjuvant S-1 was 85.8%. Median follow-up time among survivors after surgery was 4.5 years (range 0.2-5.6). Three-year RFS in intention to treat population was 72.3% (90% confidence interval [CI] 59.9-81.5), suggesting that the primary endpoint was met, and 3-year overall survival was 85.0% (90% CI 73.9-91.6). Grade 3 or higher adverse event with an incidence 10% of greater were neutropenia (13.2%), anorexia (13.2%), and diarrhea (10.5%). There was no treatment-related death. Conclusions: Adjuvant S-1 showed promising efficacy with manageable safety profile for patients with resectable ESCC after NAC-S, and warrants further evaluation in larger studies. Clinical trial information: UMIN000020204.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.4038
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
  • 10
    Online Resource
    Online Resource
    Association between c-Met expression and tumor recurrence in colorectal cancer patients after liver resection.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. 3559-3559
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 3559-3559
    Abstract: 3559 Background: c-Met is a receptor for hepatocyte growth factor that has been implicated in the pathogenesis and growth of a wide variety of human malignancies, including colorectal cancer (CRC). The aim of the present study was to clarify the correlation between c-Met protein expression in the primary lesion and relapse-free survival (RFS) in patients who had undergone curative hepatectomy for colorectal metastases. Methods: Between January 2004 and December 2009, formalin-fixed paraffin-embedded sections of surgical specimens from 108 CRC patients who had undergone hepatectomy were obtained at a single center. We performed immunohistochemical staining to detect c-Met expression. c-Met expression levels were scored dependent on staining intensity; 0, negative; 1, weak; 2, moderate; 3, strong. We defined scores 0 and 1 as c-Met-low, and scores 2 and 3 as c-Met-high. The Kaplan-Meier method and Cox proportional hazards model were used to investigate relationships between c-Met expression, patient characteristics, and RFS. Results: We identified 65 males and 43 females with a median age of 62 years. A total of 53% of patients underwent simultaneous resection of primary and metastatic liver lesions, and the others underwent metachronous resection. High levels of c-Met expression (c-Met-high) in the primary tumor were observed in 52% of patients. There were no differences in terms of size or number of metastatic liver lesions between the c-Met-low patients and the c-Met-high patients. RFS was significantly shorter in the c-Met-high patients (9.7 months) than that in the c-Met-low patients (21.1 months) in primary tumors (p=0.013). Multivariate analyses demonstrated that c-Met-high (hazards ratio [HR] , 1.73; 95% confidence interval [95% CI], 1.08-2.79 for c-Met-high vs. c-Met-low) and hepatic resection for synchronous disease (HR, 2.17; 95% CI, 1.36-3.46 for synchronous vs. metachronous resection) were associated with worse RFS. Conclusions: High levels of c-Met expression in the primary tumor were associated with shorter RFS after hepatic metastasectomy.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.3559
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...