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  • American Society of Clinical Oncology (ASCO)  (4)
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  • American Society of Clinical Oncology (ASCO)  (4)
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  • 1
    Online Resource
    Online Resource
    Circulating tumor DNA as a promising biomarker of relapse risk for stage II-III colorectal cancer.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 4079-4079
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 4079-4079
    Abstract: 4079 Background: About 30-50% colorectal cancer patients undergoing a curative resection will experience disease recurrence ultimately. Early detection of recurrence is of great significance for improving the prognosis of colorectal cancer patients. Circulating tumor DNA (ctDNA) has been suggested to be a promising biomarker for postoperative surveillance and prognosis prediction in various cancers including colorectal cancer. However, its performance in predicting early recurrence of colorectal cancer as well as appropriate testing procedures still needs large-scale prospective studies to evaluate. Methods: A total of 246 patients with stage II-III colorectal cancer and underwent curative resection from three clinical centers of China were enrolled in this multicenter prospective cohort study. Tissue samples as well as serial plasma samples before surgery, 7 days and 6 months after surgery and 3 months interval afterwards until recurrence were collected, and subjected to deep targeted-panel sequencing containing 425 cancer-related genes. ctDNA baseline genomic alterations and dynamic changes were analyzed. Its performance in predicting early recurrence was evaluated and compared with other clinical routine investigations, including serum biomarkers CEA and CA199, and CT examination. Results: The ctDNA positive rates at baseline (before surgery) and 7 days after surgery were 72.9% and 18.1% respectively. Among 199 patients with complete survival data, 18 patients were recurrent during follow up period with a median disease-free survival of 280.5 days (114-461 days). At baseline, high clinical stage (p = 0.035), and PTEN mutation (p = 0.009) were significantly associated with increased recurrent risk; while APC mutation (p = 0.04) predicted a decreased recurrent risk. Detection of ctDNA 7 days after surgery [HR: 5.9 (1.94-17.97); p = 0.0004] or any time point before clinical recurrence [HR: 6.14 (2.3-16.38); p 〈 0.0001] was associated with a significantly higher recurrent risk, and the HR increased accordingly with ctDNA mutation level. In multivariate analyses, ctDNA status was independently associated with relapse after adjusting for known clinicopathological risk factors. CEA status was not significantly (p 〉 0.4) associated with disease-free survival. A risk scoring model comprising of clinical variables and ctDNA detection after surgery was constructed and can predict 18-month recurrence with an AUC of 0.77. Conclusions: ctDNA is a promising marker of risk stratification, and early relapse detection in resected stage II/III CRC patients. Clinical trial information: NCT03312374 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.4079
    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
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    Online Resource
  • 2
    Online Resource
    Online Resource
    Updated results and biomarker analyses from the phase 2 trial (BBCAPX study) of sintilimab plus bevacizumab and CapeOx as first-line treatment in patients with RAS-mutant, microsatellite stable, unresectable metastatic colorectal cancer.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 2606-2606
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 2606-2606
    Abstract: 2606 Background: RAS-mutant and microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients have an immunosuppressive microenvironment and show a low response rate to immunotherapy. Sintilimab plus bevacizumab and CapeOX (BBCAPX) has proved its efficacy and safety in above unresectable mCRC patients (Xuefeng Fang et al. ASCO 2022). Here, we report updated efficacy, safety, progression-free survival (PFS) data and biomarker analyses from this single arm, open-label, phase 2 trial (NCT05171660). Methods: RAS-mutant and MSS mCRC patients received sintilimab (200 mg, day 1) plus bevacizumab (7.5mg/kg, day 1) and oxaliplatin (135 mg/m 2 , day 1) and capecitabine (1g/m 2 , bid, day 1-14) of each 21-day cycle. Clinical response was assessed every 2 cycles via RECIST 1.1 criteria. Whole exome sequencing (WES) and 289 NanoString panel RNA sequencing was performed for tumor mutational burden, genomic alteration, immune microenvironment and other biomarker analysis. Results: 25 patients with unresectable metastases were enrolled after the assessment of CRC multidisciplinary team. 2 (8.0%) patients showed complete response (CR), 19 (76.0%) patients had a partial response (PR) and 4 (16.0%) had stable disease. Objective response rate (ORR) reached 84.0% and disease control rate was 100.0%. The median PFS was 18.2 months for the full analysis set. The most common treatment-related adverse events (TRAEs) in all grades were anemia (21/25, 84.0%), neutropenia (20/25, 80.0%) and hand-foot syndrome (14/25, 56.0%). The most frequent grade 3 or 4 TRAEs were neutropenia (3/25, 12.0%) and alanine transaminase increased (2/25, 8.0%). No grade 5 adverse events occurred. In biomarker exploration, after treatment, as compared with the baseline, the results of WES suggested 5 patients appeared TTN/OBSCN “double-hit” and copy number variants burden was significantly decreased in tumor tissues. Nanostring panel RNA sequencing analysis found that there was a better tumor immune microenvironment cell infiltration in CR/PR patients compared with non-CR/PR patients tumors as well as PFS-long group (＜12.5 months) compared with PFS-short group (≥12.5 months). Conclusions: Combination treatment of sintilimab plus bevacizumab and CapeOX as first-line treatment demonstrated a high ORR (84.0%) and a manageable safety profile in RAS-mutant, MSS unresectable mCRC. Exploratory biomarker assessment analysis showed some patients changed into “immune-hot” subtype after the treatment. We are launching a phase 3, randomized, open-label, multicentric clinical trial (NCT04194359) to further evaluate the effect, safety and prognostic biomarkers of this combination in RAS mutant, MSS mCRC patients when compared with that of bevacizumab and CapeOX. Clinical trial information: NCT05171660 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.2606
    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
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    Online Resource
  • 3
    Online Resource
    Online Resource
    A phase 2 trial of sintilimab (IBI 308) in combination with CAPEOX and bevacizumab (BBCAPX) as first-line treatment in patients with RAS-mutant, microsatellite stable, unresectable metastatic colorectal cancer.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 3563-3563
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 3563-3563
    Abstract: 3563 Background: The prognosis of metastatic colorectal cancer (mCRC) patients with RAS gene mutation and microsatellite stable (MSS) is poor. MSS patients account for 95% of CRC and have a low response rate to immunotherapy. Previous studies have reported that chemotherapy and anti-angiogenesis therapy can promote immunotherapy response. This study aims to assess the safety and antitumor activity of sintilimab (IBI308) combined with CapeOx and bevacizumab in the first-line treatment of patients with RAS-mutant and MSS mCRC. Methods: This is an open-label, single-arm, phase II trial. Eligible patients were aged 18 to 75 years with histologically confirmed unresectable metastatic colorectal adenocarcinoma by multidisciplinary team, and had RAS gene mutation and confirmed MSS status. All patients received treatment with sintilimab (200 mg, day 1) plus bevacizumab (7.5mg/kg, day 1) and oxaliplatin (135 mg/m 2 , day 1) and capecitabine (1g/m 2 , bid, day 1-14) of each 21-day cycle. The primary endpoint included objective response rate (ORR) evaluated via RECIST 1.1 criteria and adverse events according to CTCAE 5.0. Secondary endpoint was progression-free survival (PFS). Results: 25 patients were enrolled and received at least two cycle treatment. At baseline, median age was 60 years (range 45-74), 72% of patients were male, ECOG PS 0/1 was 100%, 60% had liver metastases (mets), and the primary tumor site was right-sided colon in 36.0% and left-side colorectum in 64.0%. 25 patients completed at least one efficacy evaluation. 2 (8.0%) patients showed complete response (CR), 19 (76.0%) patients had a partial response (PR) and 4 (16.0%) had stable disease (SD). Patients with liver or lung mets had a higher ORR (93.3% and 100%, respectively) compared to the overall ORR (84.0%). Disease control rate (DCR) reached 100%. Median PFS has not yet reached. No grade 5 adverse events occurred. The most common treatment-related adverse events (TRAEs) in all grades were anemia (19/25, 76.0%), peripheral neurotoxicity (6/25, 24.0%) and neutropenia (17/25, 68.0%). The most frequent grade 3/4 TRAEs were neutropenia (3/25, 12.0%), elevated aspartate transaminase (1/25, 4.0%), elevated alanine transaminase (1/25, 4.0%) and elevated bilirubin (1/25, 4.0%). Conclusions: Combination treatment with sintilimab (IBI308) plus CapeOx and bevacizumab demonstrated a high ORR (84.0%; 93.3% in patients with liver mets, and 100% in patients with lung mets) and a manageable safety profile in RAS-mutant and MSS mCRC. Clinical trial information: NCT05171660. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.3563
    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
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    Online Resource
  • 4
    Online Resource
    Online Resource
    Short-term outcomes of laparoscopy-assisted versus open surgery for low rectal cancer (LASRE): A multicenter, randomized, controlled trial.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 3516-3516
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 3516-3516
    Abstract: 3516 Background: The efficacy of laparoscopic versus open surgery for low rectal cancer has not yet been established. We aimed to evaluate whether laparoscopic surgery is non-inferior to open surgery for low rectal cancer in terms of oncologic outcomes. Methods: LASRE trial (NCT01899547) is a multicenter, noninferiority, randomized controlled trial being conducted in 22 tertiary hospitals across China. Patients with low rectal cancer and without evidence of pelvic lateral lymph nodes or distant metastasis were randomly assigned (2:1) to laparoscopic or open surgery. The primary outcome was 3-year disease-free survival (DFS). Secondary outcomes included pathological outcomes, 30-day postoperative complications, 30-day mortality, overall survival (OS), and quality of life. The target sample size was 1065 patients. The short-term pathological, surgical, and postoperative recovery outcomes, analyzed in a modified intention-to-treat population (mITT). Results: Between November 12, 2013, and June 6, 2018, 1070 patients were randomized into laparoscopic (n = 712) or open surgery (n = 358) groups; 1039 were included in the mITT analysis (685 in laparoscopic and 354 in open group). Seventeen patients (2.5%) in the laparoscopic group required conversion to open surgery. There were no significant between-group differences in the rates of complete mesorectal excision (85.3% vs. 85.8%; p = 0.777), negative circumferential resection margins (98.2% vs. 99.7%; p = 0.085), negative distal resection margins (99.4% vs. 100%; p = 0.362), and numbers of retrieved lymph nodes (13.0 vs. 12.0; p = 0.394). The laparoscopic surgery group exhibited a shorter time to first flatus (40.4 vs. 44.8 hours; p = 0.006), time to first defecation (61.2 vs. 66.3 hours; p = 0.031), duration of analgesic use (45.0 vs. 48.0 hours; p = 0.001), and duration of hospitalization (8.0 vs. 9.0 days; p = 0.008) compared to the open surgery group. The postoperative complication rates were 13.0% and 17.2% in the laparoscopic and open surgery groups, respectively (p = 0.065). There was no incidence of 30-day mortality. Conclusions: In patients with low rectal cancer, laparoscopic surgery performed by experienced surgeons can provide pathological outcomes comparable with those of open surgery in terms of complete mesorectal excision and negative resection margins, rapid postoperative recovery, and fewer postoperative complications. Clinical trial information: NCT01899547.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.3516
    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
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    Online Resource
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