1.Albumin-bound paclitaxel plus anlotinib in patients with recurrent, platinum-resistant primary epithelial ovarian cancer (A-Plus): a phase II, single-arm, prospective study.
Yun ZHOU ; Jian ZHOU ; Yin WANG ; Ji-Bin LI ; Rongzhen LUO ; Chanjuan ZENG ; Yingxin HE ; Yanfang LI
Frontiers of Medicine 2025;19(5):820-830
This study aimed to evaluate the efficacy and safety of combining albumin-bound paclitaxel (abpaclitaxel) and anlotinib for ovarian cancer. In this study, 44 patients diagnosed with platinum-resistant ovarian cancer were enrolled. Patients received ab-paclitaxel along with anlotinib until disease progression or intolerable toxicity. Efficacy was assessed according to RECIST 1.1 criteria or Rustin's criteria. The primary endpoint was the investigator-evaluated objective response rate (ORR). 44 patients were enrolled between January 2021 and March 2023 with a median age of 49 years. Twenty-nine had measurable lesions and 15 had non-measurable lesions. Overall, the investigator-evaluated ORR was 56.8% (25/44; 95% CI 0.411-0.713) in intention-to-treat population and 58.1% (25/43; 95% CI 0.422-0.726) in per-protocol population. The median progression-free survival was 9.8 months, and the median duration of response was 7.4 months. For safety, grade 3/4 adverse events (AEs) included leukopenia, gum pain, hypertension, and hand-foot syndrome. The response rates were 55.0% (11/20) in patients with previous use of antiangiogenic reagents and who had previous use of PARP inhibitors. The combination of ab-paclitaxel and anlotinib showed promising anti-tumor activity and a manageable safety profile in platinum-resistant ovarian cancer. Patients with previous use of antiangiogenic drugs or PARP inhibitors still benefited from this protocol.
Humans
;
Female
;
Middle Aged
;
Indoles/therapeutic use*
;
Quinolines/therapeutic use*
;
Carcinoma, Ovarian Epithelial/drug therapy*
;
Adult
;
Ovarian Neoplasms/drug therapy*
;
Prospective Studies
;
Antineoplastic Combined Chemotherapy Protocols/administration & dosage*
;
Aged
;
Drug Resistance, Neoplasm
;
Albumin-Bound Paclitaxel/therapeutic use*
;
Neoplasm Recurrence, Local/drug therapy*
;
Progression-Free Survival
;
Paclitaxel/administration & dosage*
;
Treatment Outcome
2.Olaparib and niraparib as maintenance therapy in patients with newly diagnosed and platinum-sensitive recurrent ovarian cancer: A single-center study in China.
Dengfeng WANG ; Xunwei SHI ; Jiao PEI ; Can ZHANG ; Liping PENG ; Jie ZHANG ; Jing ZHENG ; Chunrong PENG ; Xiaoqiao HUANG ; Xiaoshi LIU ; Hong LIU ; Guonan ZHANG
Chinese Medical Journal 2025;138(10):1194-1201
BACKGROUND:
Poly adenosine-diphosphate-ribose polymerase (PARP) inhibitors (PARPi) have been approved to act as first-line maintenance (FL-M) therapy and as platinum-sensitive recurrent maintenance (PSR-M) therapy for ovarian cancer in China for >5 years. Herein, we have analyzed the clinical-application characteristics of olaparib and niraparib in ovarian cancer-maintenance therapy in a real-world setting to strengthen our understanding and promote their rational usage.
METHODS:
A retrospective chart review identified patients with newly diagnosed or platinum-sensitive recurrent ovarian cancer, who received olaparib or niraparib as maintenance therapy at Sichuan Cancer Hospital between August 1, 2018, and December 31, 2021. Patient medical records were reviewed. We grouped and analyzed patients based on the type of PARPi they used (the olaparib group and the niraparib group) and the line of PARPi maintenance therapy (the FL-M setting and the PSR-M setting). The primary endpoint was the 24-month progression-free survival (PFS) rate.
RESULTS:
In total, 131 patients (olaparib: n = 67, 51.1%; niraparib: n = 64, 48.9%) were enrolled. Breast cancer susceptibility genes ( BRCA ) mutations ( BRCA m) were significantly less common in the niraparib group than in the olaparib group [9.4% (6/64) vs . 62.7% (42/67), P <0.001], especially in the FL-M setting [10.4% (5/48) vs . 91.4% (32/35), P <0.001]. The 24-month progression-free survival (PFS) rates in the FL-M and PSR-M settings were 60.4% and 45.7%, respectively. In patients with BRCA m, the 24-month PFS rates in the FL-M and PSR-M settings were 62.2% and 72.7%, respectively.
CONCLUSIONS
Olaparib and niraparib were effective in patients with ovarian cancer without any new safety signals except for skin pigmentation. In patients with BRCA m, the 24-month PFS of the PARPi used in the PSR-M setting was even higher than that used in the FL-M setting.
Humans
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Female
;
Ovarian Neoplasms/drug therapy*
;
Piperazines/therapeutic use*
;
Middle Aged
;
Retrospective Studies
;
Phthalazines/therapeutic use*
;
Piperidines/therapeutic use*
;
Indazoles/therapeutic use*
;
Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use*
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Adult
;
Aged
;
China
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Neoplasm Recurrence, Local/drug therapy*
;
Progression-Free Survival
3.Efficacy and safety of immune checkpoint inhibitors in the treatment of recurrent or metastatic nasopharyngeal carcinoma: A systematic review and meta-analysis.
Zhixin YU ; Shaodong HONG ; Hui YU ; Xuanye ZHANG ; Zichun LI ; Ping CHEN ; Yixin ZHOU
Chinese Medical Journal 2025;138(5):531-539
BACKGROUND:
The combination of immune checkpoint inhibitors and chemotherapy (ICI + Chemo) shows promise in treatment of recurrent or metastatic nasopharyngeal carcinoma (RM-NPC), but some patients received limited benefit and the prognostic factors of the treatments remain unclear. Furthermore, ICIs efficacy in subsequent treatments needs further evaluation.
METHODS:
A systematic search on PubMed, Embase, the Cochrane Library, and major conference proceedings was conducted to identify relevant studies for meta-analysis. The study was designed to compare ICI + Chemo with chemotherapy in first-line treatment and identify efficacy predictors, and to evaluate ICIs alone in subsequent-line treatment for RM-NPC, with a focus on progression-free survival (PFS), objective response rate (ORR), and treatment-related adverse events (AEs).
RESULTS:
Fifteen trials involving 1928 patients were included. Three trials compared ICI + Chemo with chemotherapy as a first-line treatment, while 12 trials evaluated ICIs alone in subsequent-line treatment of RM-NPC patients. First-line ICI + Chemo showed superior PFS (hazard ratio [HR] = 0.52, 95% confidence interval [CI], 0.43-0.63; P <0.001) and ORR (risk ratio [RR] = 1.14, 95% CI, 1.05-1.24; P <0.001) compared to chemotherapy, without increased AEs (RR = 1.01, 95% CI, 0.99-1.03; P = 0.481). Neither programmed death-ligand 1 (PD-L1) nor other factors predicted the efficacy of ICI + Chemo vs . chemotherapy. Subsequent-line ICIs alone had a median PFS of 4.12 months (95% CI, 2.93-5.31 months), an ORR of 24% (95% CI, 20-28%), with grade 1-5/grade 3-5 AEs at 79%/14%. However, ICIs alone were associated with significantly shorter PFS (HR = 1.31, 95% CI, 1.01-1.68; P = 0.040) than chemotherapy alone.
CONCLUSIONS
ICI + Chemo confers superior survival benefits compared to chemotherapy in first-line RM-NPC treatment, independent of PD-L1 expression or other factors. However, ICIs alone demonstrate a manageable safety profile but do not surpass chemotherapy in efficacy for subsequent-line treatment.
Humans
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Immune Checkpoint Inhibitors/adverse effects*
;
Nasopharyngeal Carcinoma/drug therapy*
;
Nasopharyngeal Neoplasms/drug therapy*
;
Neoplasm Recurrence, Local/drug therapy*
5.Research Progress in Immune Checkpoint Inhibitors for Relapsed and Refractory Malignant Gonadal Germ Cell Tumors.
Acta Academiae Medicinae Sinicae 2025;47(1):131-136
Germ cell tumors typically occur in the gonadal regions,characterized by high malignancy and rapid progression.Due to their high sensitivity to chemotherapy,the cure rate is generally high.However,a portion of patients still succumb to chemotherapy resistance and disease progression.The use of immune checkpoint inhibitors has significantly improved the prognosis for various solid tumors,while the immune mechanisms and efficacy of immunotherapy in germ cell tumors remain understudied.Whether relapsed and refractory germ cell tumors can benefit from immune checkpoint inhibitors remains to be investigated.In this review,we summarize the immune-related mechanisms,case reports,and clinical trials of immunotherapy in germ cell tumors to assess the effectiveness of this therapy,providing a reference for future basic research and clinical practice.
Humans
;
Neoplasms, Germ Cell and Embryonal/therapy*
;
Immune Checkpoint Inhibitors/therapeutic use*
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Immunotherapy
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Testicular Neoplasms/drug therapy*
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Neoplasm Recurrence, Local
;
Drug Resistance, Neoplasm
7.Evaluation strategy of complete response after neoadjuvant therapy for rectal cancer.
Chinese Journal of Surgery 2023;61(9):738-743
Currently, the standard of clinical complete response (cCR) after neoadjuvant chemoradiotherapy (nCRT) for local advanced rectal cancer generally lacks pathological examination, the cCR judged by the current standard is still far from the real pathological complete response. After nCRT, due to the presence of tissue edema and fibrosis, MRI is highly uncertain in determining the staging of local lesions. The precision of colonoscopy biopsy is generally low because residual cancer foci exist primarily in the muscular layer, which limits the determination of cCR by colonoscopy biopsy. Local excision through the anus can resect the whole intestinal wall tissue, which is relatively accurate and close to the real state of remission of the lesion, but there are many problems, such as affecting anal function, high rate of complications, and increased difficulty of following radical surgery. Based on the present diagnosis of cCR, the authors put forward the concept of modified cCR (m-cCR) which combined with the pathological standard of transanal multipoint full-layer puncture biopsy. It is possible to improve the accuracy of cCR, and improve the safety of cCR patients who receive wait-and-watch therapy without increasing complications or affecting anal function. The exact conclusion needs to be confirmed by further studies.
Humans
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Neoadjuvant Therapy
;
Treatment Outcome
;
Neoplasm Recurrence, Local/diagnosis*
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Watchful Waiting
;
Rectal Neoplasms/surgery*
;
Chemoradiotherapy
8.Chinese expert consensus on the application of circulating tumor cell detection in the diagnosis and treatment of gastrointestinal neoplasms (2023 edition).
Chinese Journal of Gastrointestinal Surgery 2023;26(11):1001-1007
Circulating tumor cell (CTC), as a novel tumor marker, has the characteristics of non-invasive, dynamic monitoring and high accuracy, and provides precise molecular characteristics of tumors and helps understand the changes in tumor development. Therefore, CTC has important clinical value in the dynamic monitoring of tumor progression. In order to standardize and guide the application of CTC detection in the diagnosis and treatment of gastrointestinal neoplasms, Gastric Cancer Group of Oncology Branch of Chinese Medical Association, Colorectal Cancer Professional Committee of Chinese Medical Doctor Association, Colorectal Cancer Professional Committee of Chinese Anti-Cancer Association, Gastric Cancer Professional Committee of Chinese Anti-Cancer Association, Digestive Tract Polyp and Precancerous Lesion Professional Committee of Chinese Anti-Cancer Association, jointly convened some domestic experts to discuss and formulate the Chinese expert consensus on the application of circulating tumor cell detection in the diagnosis and treatment of gastrointestinal neoplasms (2023 edition). The consensus provides opinions on the detection technology and clinical application of CTC detection in the diagnosis and treatment of gastrointestinal neoplasms, including the prediction of tumor prognosis, the monitoring of tumor recurrence and metastasis, the evaluation of treatment response, and the additional diagnostic value, providing guidance for clinical application.
Humans
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Stomach Neoplasms/therapy*
;
Neoplastic Cells, Circulating/pathology*
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Consensus
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Neoplasm Recurrence, Local
;
Colorectal Neoplasms/therapy*
10.Evaluation of lateral lymph node metastasis in mid-low rectal cancer and planning of multi-disciplinary treatment.
Chinese Journal of Gastrointestinal Surgery 2023;26(1):51-57
After the implementation of neoadjuvant chemoradiotherapy and total mesorectal excision, lateral local recurrence becomes the major type of local recurrence after surgery in rectal cancer. Most lateral recurrence develops from enlarged lateral lymph nodes on an initial imaging study. Evidence is accumulating to support the combined use of neoadjuvant chemoradiotherapy and lateral lymph node dissection. The accuracy of diagnosing lateral lymph node metastasis remains poor. The size of lateral lymph nodes is still the most commonly used variable with the most consistent accuracy and the cut-off value ranging from 5 to 8 mm on short axis. The morphological features, differentiation of the primary tumor, circumferential margin, extramural venous invasion, and response to chemoradiotherapy are among other risk factors to predict lateral lymph node metastasis. Planning multiple disciplinary treatment strategies for patients with suspected nodes must consider both the risk of local recurrence and distant metastasis. Total neoadjuvant chemoradiotherapy is the most promising regimen for patients with a high risk of recurrence. Simultaneous Integrated Boost Intensity-Modulated Radiation Therapy seemingly improves the local control of positive lateral nodes. However, its impact on the safety of surgery in patients with no response to the treatment or regrowth of lateral nodes remains unclear. For patients with smaller nodes below the cut-off value or shrunken nodes after treatment, a close follow-up strategy must be performed to detect the recurrence early and perform a salvage surgery. For patients with stratified lateral lymph node metastasis risks, plans containing different multiple disciplinary treatments must be carefully designed for long-term survival and better quality of life.
Humans
;
Lymphatic Metastasis/pathology*
;
Quality of Life
;
Neoplasm Staging
;
Retrospective Studies
;
Lymph Nodes/pathology*
;
Rectal Neoplasms/surgery*
;
Lymph Node Excision/methods*
;
Neoadjuvant Therapy/methods*
;
Neoplasm Recurrence, Local/surgery*

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