scholarly journals Clinicopathological features and outcomes in gastric-type of HPV-independent endocervical adenocarcinomas

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lili Chen ◽  
Yizhen Niu ◽  
Xiaoyun Wan ◽  
Lina Yu ◽  
Xiaofei Zhang ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Clinical Stage ◽  
Progression Free Survival ◽  
Clinicopathological Features ◽  
Stromal Invasion ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Gastric Type ◽  
Minimal Deviation ◽  
Cervical Stromal Invasion

Abstract Background We aimed to analyze the clinicopathological features and outcomes of patients with gastric-type of HPV-independent endocervical adenocarcinoma (GAS HPVI ECA), and compare them with non-GAS HPVI ECA cases. Methods Thirty-eight GASs [including 17 minimal deviation adenocarcinoma (MDA), 21 non-MDA GAS] and 17 non-GAS HPVI ECAs were studied. Data of clinical features, pathological characteristics, treatment, and outcomes were evaluated. Results The median age of patients with GAS and non-GAS HPVI ECA was 46 and 48 years, respectively (p = 0.93). Compared with non-GAS HPVI ECAs, GAS had more common complains of vaginal watery discharge (p = 0.04). GAS cases were also associated with higher clinical stage (p = 0.036), more common in deeper cervical stromal invasion (p = 0.002) and lymphoavascular invasion (p = 0.044). GAS was associated with worse median progression-free survival (PFS) (p = 0.02) and median overall survival (OS) (p = 0.03) over patients with non-GAS HPVI ECAs. MDA had similar clinical and pathological features and prognosis compared with non-MDA GAS. Of note, serum CA19–9 levels were significantly higher in GAS than that in non-GAS HPVI ECA cases. Conclusions GAS cases were more likely to have high risk pathological factors and poorer PFS and OS compared with non-GAS HPVI ECAs. Serum CA19–9 may be helpful for diagnosis and screening in patients with GAS.

scholarly journals Clinicopathological features and outcomes in different histologic subtypes of HPV-independent endocervical adenocarcinomas

2021 ◽  
Author(s):  
Lili Chen ◽  
Yizhen Niu ◽  
Xiaoyun Wan ◽  
Lina Yu ◽  
Xiaofei Zhang ◽  
...  
Keyword(s):  
Clinical Presentation ◽  
Clinical Stage ◽  
Progression Free Survival ◽  
Clinicopathological Features ◽  
Stromal Invasion ◽  
Free Survival ◽  
Significant Difference ◽  
Minimal Deviation ◽  
Cervical Stromal Invasion ◽  
Histologic Subtypes

Abstract Background: We aim to analyze the clinicopathological features and outcomes among different histologic subtypes of HPV-independent endocervical adenocarcinomas（HPVI ECAs).Methods: Forty-five HPVI ECAs, including 16 minimal deviation adenocarcinoma (MDA), 17 non-MDA type of gastric adenocarcinoma (GAS), and 12 non-GAS HPVI ECAs were studied. Data of clinical features, pathological characteristics, treatment, and outcomes were evaluated. Results: The median age of patients with GAS was 46 years old (IQR: 41.5, 59.5), with no significant difference compared to patients with non-GAS HPVI ECA (48-year-old, IQR: 40.5, 60.5) (p=0.92). Compared with non-GAS HPVI ECAs, GAS hade more common complains of vaginal watery discharge (p=0.047). GAS cases were also associated with higher clinical stage at diagnosis (P=0.016), deeper cervical stromal invasion (p=0.01), and worse 5-year progression free survival (PFS) (p=0.032). Compared with non-MDA GAS, MDA had similar clinical and pathological features and prognosis. Of note, cytology results showed a lower positivity rate for HPVI ECAs (65.2% for GAS and 60% for non-GAS HPVI ECA), and MDA had a lower positivity rate than that for non-MDA (40.0% vs 84.6%, p=0.026). Serum CA19-9 levels were significantly higher in MDA than those in non-MDA (184.5 U/ml vs 22.4U/ml, p=0.045) and non-GAS cases (184.5U/ml vs 10.6U/ml, p=0.006).Conclusions: GAS HPVI ECA had different clinical presentation with genital watery discharge compared with non-GAS HPVI ECA cases. Comparison with those of non-GAS HPVI ECAs, GAS cases were more likely to have high risk pathological factors and poorer PFS. Serum CA19-9 may be helpful for diagnosis and screening in patients with GAS, especially those with MDA.

Use of nab-paclitaxel and gemcitabine in pancreatic cancer without granulocyte colony-stimulating factor: A multicenter real-world experience

2021 ◽  
pp. 107815522110386
Author(s):  
Angela Chen ◽  
Vincent H Ha ◽  
Sunita Ghosh ◽  
Carole R Chambers ◽  
Michael B Sawyer
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Median Overall Survival ◽  
Progression Free Survival ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Free Survival ◽  
Colony Stimulating Factors ◽  
Median Progression Free Survival ◽  
Stimulating Factor

Introduction The metastatic pancreatic adenocarcinoma clinical trial (MPACT) trial established gemcitabine (gem) and nab-paclitaxel (nab) as a standard treatment for pancreatic cancer utilizing granulocyte colony-stimulating factors to manage neutropenia. This was a challenge for jurisdictions that do not use granulocyte colony-stimulating factors in palliative settings. We developed dosage guidelines to dose modify gem and nab without granulocyte colony-stimulating factors. We undertook a retrospective review to determine the efficacy and safety of these dose adjustment guidelines in the real world. Methods A multi-centered, retrospective chart review was performed on pancreatic patients between December 1, 2014, and August 21, 2018. Provincial electronic medical health records were reviewed. Using Log-rank statistics we determined the patient's progression-free survival and overall survival. Results Of 248 patients, 209 met patient selection criteria. Patients were excluded if they were lost to follow-up, on gem alone prior to nab/gem combination therapy or did not receive nab or gem. Patients who received nab/gem as first-line therapy had a median progression-free survival of 6.3 months (95% CI, 5.1–7.4), and median overall survival of 11.1 months (95% CI, 9.5–12.8). Those who received gem/nab in the second line had a median progression-free survival of 4.6 months (95% CI, 2.8–6.5), and median overall survival of 19.3 months (95% CI, 12.6–26.0). Conclusions The patient’s progression-free survival and overall survival taking nab/gem using our dose modification algorithm were equivalent or superior to the MPACT trial's progression-free survival and overall survival. Gem/nab can be given by our dose modification scheme without granulocyte colony-stimulating factor.

scholarly journals Prognostic implications of PD-L1 expression in patients with angiosarcoma

2021 ◽  
pp. FSO691
Author(s):  
Jii Bum Lee ◽  
Beung-Chul Ahn ◽  
Seung Hyun Kim ◽  
Young Han Lee ◽  
Jung Woo Han ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Overall Survival ◽  
Prognostic Biomarker ◽  
Progression Free Survival ◽  
Limited Data ◽  
Free Survival ◽  
Programmed Death Ligand 1 ◽  
Median Progression Free Survival ◽  
Programmed Death ◽  
Prognostic Implications

Aim: There are limited data on the feasibility of programmed death ligand-1 (PD-L1) expression as a prognostic biomarker in metastatic angiosarcoma. Patients & methods: We retrospectively collected and analyzed the data on PD-L1 expression in 70 angiosarcoma patients who were diagnosed at our center between 2005 and 2019. Results: Thirteen (19%) patients had PD-L1 expression. Metastatic angiosarcoma patients who were PD-L1-negative (n = 24) showed longer median progression-free survival (4.9 vs 1.6 months; p = 0.04) and median overall survival (OS; 10.9 vs 5.4 months; p = 0.01) than those who were PD-L1-positive (n = 4). PD-L1 status proved to be a significant factor for OS. Conclusion: Metastatic angiosarcoma patients with PD-L1 expression showed shorter survival. PD-L1 status is an independent prognostic factor for OS in metastatic angiosarcoma patients.

scholarly journals What Has Changed in the Management of Uterine Serous Carcinomas? Two Decades of Experience

2021 ◽  
Vol 28 (6) ◽  
pp. 4862-4873
Author(s):  
Michalis Liontos ◽  
Anna Svarna ◽  
Charalampos Theofanakis ◽  
Oraianthi Fiste ◽  
Angeliki Andrikopoulou ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Overall Survival ◽  
De Novo ◽  
Disease Free Survival ◽  
Progression Free Survival ◽  
Treatment Modalities ◽  
Serous Carcinoma ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Endometrial Carcinomas

Uterine serous carcinoma accounts for 3–10% of endometrial cancers, but it is the most lethal histopathological subtype. The molecular characterization of endometrial carcinomas has allowed novel therapeutic approaches for these patients. We undertook a retrospective analysis of patients with uterine serous carcinomas treated in our hospital within the last two decades to identify possible changes in their management. The patients and their characteristics were evenly distributed across the two decades. Treatment modalities did not change significantly throughout this period. After adjuvant treatment, patients’ median disease-free survival was 42.07 months (95% CI: 20.28–63.85), and it did not differ significantly between the two decades (p = 0.059). The median overall survival was 47.51 months (95% Cl: 32.18–62.83), and it significantly favored the first decade’s patients (p = 0.024). In patients with de novo metastatic or recurrent disease, median progression-free survival was 7.8 months (95% Cl: 5.81–9.93), whereas both the median progression-free survival and the median overall survival of these patients did not show any significant improvement during the examined time period. Overall, the results of our study explore the minor changes in respect of uterine serous carcinoma’s treatment over the last two decades, which are reflected in the survival outcomes of these patients and consequently underline the critical need for therapeutic advances in the near future.

scholarly journals Nanoliposomal irinotecan plus fluorouracil and folinic acid as a second-line treatment option in patients with metastatic pancreatic ductal adenocarcinoma: a retrospective cohort study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Se Jun Park ◽  
Hyunho Kim ◽  
Kabsoo Shin ◽  
Tae Ho Hong ◽  
Ja Hee Suh ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Median Overall Survival ◽  
Progression Free Survival ◽  
Ductal Adenocarcinoma ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Nanoliposomal Irinotecan ◽  
Previously Treated

Abstract Background According to the NAPOLI-1 trial, nanoliposomal irinotecan (nal-IRI) plus fluorouracil/folinic acid (5-FU/LV) showed improved overall survival compared to fluorouracil alone for patients with metastatic pancreatic cancer who were previously treated with gemcitabine-based therapy. In that trial, Asian patients had frequent dose modification due to haematological toxicity. There has been limited information on the clinical benefits and toxicity of this regimen in real-world settings. In this study, we assessed real-world experience of nal-IRI plus 5-FU/LV in patients with advanced pancreatic cancer after gemcitabine failure. Methods We conducted a single institution, retrospective analysis of response, survival and safety in patients who had been treated with nal-IRI with 5-FU/LV. Patients with metastatic pancreatic ductal adenocarcinoma previously treated with gemcitabine-based therapy received nal-IRI (80 mg/m2) with 5-FU/LV every 2 weeks. Kaplan-Meier analysis was performed to obtain median progression free survival and median overall survival. The hazard ratio and 95% confidence interval (CI) were estimated using a stratified Cox regression model. A multivariate Cox proportional hazards regression model was used to identify the effects of clinical factors. Results Fifty-one patients received nal-IRI plus 5-FU/LV between January 2015 and December 2020. The median age was 67 years, and males were 58.8%. A total of 40 (78.4%) and 11 (21.6%) patients had received one and two lines of prior chemotherapy before enrollment, respectively. Median progression-free survival was 2.8 months (95% CI 1.8–3.7) and median overall survival was 7.0 months (95% CI 6.0–7.9). Chemotherapy doses were reduced or delayed in 33 (64.7%) patients during the first 6 weeks and median relative dose intensity was 0.87. Thirty-six (70.6%) patients experienced grade 3 or 4 adverse events, most commonly neutropenia (58.8%). Most non-haematologic adverse events were under grade 2. Since the start of first-line chemotherapy, median overall survival was 16.3 months (95% CI 14.1–18.4). Conclusions Nal-IRI plus 5-FU/LV seems to be effective, with manageable toxicities, following gemcitabine-based treatment in patients with metastatic pancreatic ductal adenocarcinoma. Nal-IRI plus 5-FU/LV following gemcitabine with nab-paclitaxel is a feasible sequential treatment option in patients with metastatic pancreatic cancer. Trial registration Retrospectively registered.

Clinical and utilization outcomes associated with tumor mutational burden in a real-world pan-tumor population

2021 ◽  
Author(s):  
Santosh Gautam ◽  
Sumesh Kachroo ◽  
Richard W DeClue ◽  
Maxine D Fisher ◽  
Anirban Basu
Keyword(s):  
Real World ◽  
Median Overall Survival ◽  
Progression Free Survival ◽  
Cost Of Care ◽  
Advanced Solid Tumor ◽  
Limited Sample ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Mutational Burden ◽  
Tumor Mutational Burden

Aim & methods: This real-world study examined the association of tumor mutational burden (TMB) with clinical and healthcare utilization in adults diagnosed with advanced solid tumor 1 January 2015– 31 January 2019. Results: There were 170 patients in low-TMB group (TMB<10 mut/Mb) and 32 in high-TMB group (TMB ≥10 mut/Mb). Median overall survival was 18.8 (95% CI: 17.3–28.8) and 15.9 months (95% CI: 11.3–18.0) whereas median progression-free survival was 9.9 (95% CI: 8.6–11.4) and 7.8 months (95% CI: 3.8–12.5) for the low- and high-TMB groups, respectively. Hospitalization (49.4 vs 37.5%), emergency visit (25.3 vs 21.9%), and median overall cost of care (US$135,403 vs 87,570) were all lower in low-TMB group. Conclusion: Despite the limited sample, these data provide a historical perspective for examining real-world outcomes associated with TMB.

Thalidomide in Combination with Idarubicin, Dexamethasone and Etoposide (TIDE) Is an Effective Oral Combination in Heavily Pre-Treated Myeloma Patients.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4841-4841
Author(s):  
Mark D. Linch ◽  
Matthew W. Jenner ◽  
Sharon Dines ◽  
Faith E. Davies ◽  
Gareth J. Morgan
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Dose Reduction ◽  
Median Overall Survival ◽  
Response Rate ◽  
Progression Free Survival ◽  
Efficacy Data ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Grade 3

Abstract Dexamethasone, thalidomide, etoposide and an antracycline have formed part of regimens such as DT-PACE which have demonstrated efficacy in previously treated patients with multiple myeloma. They are inpatient regimens which limit their usage in a palliative setting. We have designed an oral regimen incorporating these agents. The toxicity and efficacy data of this novel treatment are presented. Between October 2004 and May 2007 patients who had progressive myeloma or were intolerant of DT-PACE were treated with 100–200mg of thalidomide on days 1–21 and four days (D1–4) of 10mg/m2 idarubicin, 40mg dexamethasone and 50mg/m2 etoposide twice daily (TIDE). All agents were administered orally on a 21 day cycle for a maximum of 5 cycles. Aciclovir, co-trimoxazole and Lansoprazole were administered routinely and G-CSF was administered in the event of neutropenic fever and as secondary prophylaxis. Thromboembolism prophylaxis was not specified. Response was assessed using the international uniform response criteria for multiple myeloma. Toxicity was assessed using the CTCAE version 3.0. Efficacy data is presented as intention to treat. Nineteen patients received TIDE chemotherapy with a median age of 60 (range 36–70) and a male to female ratio of 11:8. Patients had a median of 3 (range 1–6) previous cycles and 18/19 patients had previous thalidomide. Patients received a median of 3 cycles (range 1–5) of TIDE. The most common grade 3/4 non-haematological toxicities were infection (8 patients), thromboembolism (3 patients), nephrotoxicity (2 patients), diarrhoea (1 patient) and peripheral neuropathy (1 patient). Grade 3–4 haematological toxicity occurred in 17/19 patients but 10/19 patients had grade 1–2 ‘toxicity’ at baseline. There were no recorded toxic deaths. Out of the 8 patients that suffered neutropenic fever, 7 experienced this on their 1st cycle resulting in treatment cessation in 3 patients. With prophylactic G-CSF or dose reduction, 3 of the remaining 4 patients did not get further neutropenic sepsis. In total 6 patients required a dose reduction and 17/19 patients had G-CSF. Seven patients were anti-coagulated from the beginning of this study; 2 were on Erythropoetin, 2 had previous thromboembolism and 3 were commenced at the clinicians discretion. None of the anti-coagulated patients went on to have a thromboembolic event. 18/19 patients were evaluable for response. The overall response rate was 42% (1CR, 7PR, 9SD and 1PD). The response rate to TIDE in patients who were intolerant of inpatient DT-PACE was the same as those that were treated with TIDE alone (50% vs 45%). The median progression free survival was 4 months (range 1–12) and the median overall survival was 8 months (range 1–31). In patients who responded to TIDE the median progression free survival was 7 months (range 3–12) and the median overall survival was 10 months (range 4–23). The TIDE regimen is able to induce responses in heavily pre-treated myeloma patients, including those taking thalidomide at the time of disease progression. Toxicities are acceptable but primary prophylactic G-CSF and anticoagulation should be contemplated. Consideration should also be given to using the TIDE regimen at an earlier stage in the disease process.

scholarly journals Multicenter Phase II Study of Lurbinectedin in BRCA-Mutated and Unselected Metastatic Advanced Breast Cancer and Biomarker Assessment Substudy

2018 ◽  
Vol 36 (31) ◽  
pp. 3134-3143 ◽  
Author(s):  
Cristina Cruz ◽  
Alba Llop-Guevara ◽  
Judy E. Garber ◽  
Banu K. Arun ◽  
José A. Pérez Fidalgo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Median Overall Survival ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Multicenter Phase ◽  
Brca2 Mutations ◽  
Grade 3

Purpose This multicenter phase II trial evaluated lurbinectedin (PM01183), a selective inhibitor of active transcription of protein-coding genes, in patients with metastatic breast cancer. A unicenter translational substudy assessed potential mechanisms of lurbinectedin resistance. Patients and Methods Two arms were evaluated according to germline BRCA1/2 status: BRCA1/2 mutated (arm A; n = 54) and unselected ( BRCA1/2 wild-type or unknown status; arm B; n = 35). Lurbinectedin starting dose was a 7-mg flat dose and later, 3.5 mg/m2 in arm A. The primary end point was objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST). The translational substudy of resistance mechanisms included exome sequencing (n = 13) and in vivo experiments with patient-derived xenografts (n = 11) from BRCA1/2-mutated tumors. Results ORR was 41% (95% CI, 28% to 55%) in arm A and 9% (95% CI, 2% to 24%) in arm B. In arm A, median progression-free survival was 4.6 months (95% CI, 3.0 to 6.0 months), and median overall survival was 20.0 months (95% CI, 11.8 to 26.6 months). Patients with BRCA2 mutations showed an ORR of 61%, median progression-free survival of 5.9 months, and median overall survival of 26.6 months. The safety profile improved with lurbinectedin dose adjustment to body surface area. The most common nonhematologic adverse events seen at 3.5 mg/m2 were nausea (74%; grade 3, 5%) and fatigue (74%; grade 3, 21%). Neutropenia was the most common severe hematologic adverse event (grade 3, 47%; grade 4, 10%). Exome sequencing showed mutations in genes related to the nucleotide excision repair pathway in four of seven tumors at primary or acquired resistance and in one patient with short-term stable disease. In vivo, sensitivity to cisplatin and lurbinectedin was evidenced in lurbinectedin-resistant (one of two) and cisplatin-resistant (two of three) patient-derived xenografts. Conclusion Lurbinectedin showed noteworthy activity in patients with BRCA1/2 mutations. Response and survival was notable in those with BRCA2 mutations. Additional clinical development in this subset of patients with metastatic breast cancer is warranted.

scholarly journals Augmenting the randomized controlled trial with real-world data to aid clinical decision making in metastatic renal cell carcinoma: a systematic review and meta-analysis

2019 ◽  
Vol 15 (34) ◽  
pp. 3987-4001 ◽  
Author(s):  
Michael Moran ◽  
Dana Nickens ◽  
Katherine Adcock ◽  
Meg Bennetts ◽  
Natalie Charnley ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Median Overall Survival ◽  
Response Rate ◽  
Objective Response ◽  
Progression Free Survival ◽  
Real World Data ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Randomized Controlled

Aim: To evaluate how efficacy outcomes from real-world data (RWD) can support those from randomized controlled trials (RCTs), in the context of first-line tyrosine kinase inhibitor treatment of metastatic renal cell carcinoma. Patients & methods: PubMed, Ovid, MEDLINE and EMBASE were searched for RCTs and RWD studies with ≥50 adult patients per arm published in 2000–2017. Outcome measures were median progression-free survival, median overall survival and objective response rate. Results: A total of 13 RCTs and 22 RWD studies met eligibility criteria; 31, 28 and 25 studies, respectively, reported median progression-free survival, median overall survival and objective response rate. Summary outcome measures were similar in RWD and RCTs. Conclusion: RWD validates efficacy-based outcomes from RCTs and may provide supportive evidence to inform clinical decisions.

scholarly journals Efficacy and Safety of Bevacizumab Plus Erlotinib in Patients with Renal Medullary Carcinoma

Cancers ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 2170
Author(s):  
Andrew J. Wiele ◽  
Devaki Shilpa Surasi ◽  
Priya Rao ◽  
Kanishka Sircar ◽  
Xiaoping Su ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Overall Survival ◽  
Progression Free Survival ◽  
Medullary Carcinoma ◽  
Tumor Burden ◽  
Efficacy And Safety ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Renal Medullary Carcinoma ◽  
Grade 3

Purpose: To assess the efficacy and safety of bevacizumab plus erlotinib in patients with RMC. Methods: We retrospectively reviewed the records of patients with RMC treated with bevacizumab plus erlotinib at our institution. Results: Ten patients were included in the study. Two patients achieved a partial response (20%) and seven patients achieved stable disease (70%). Tumor burden was reduced in seven patients (70%) in total, and in three out of five patients (60%) that had received three or more prior therapies. The median progression-free survival (PFS) was 3.5 months (95% CI, 1.8–5.2). The median overall survival (OS) from bevacizumab plus erlotinib initiation was 7.3 months (95% CI, 0.73–13.8) and the median OS from diagnosis was 20.8 months (95% CI, 14.7–26.8). Bevacizumab plus erlotinib was well tolerated with no grade ≥4 adverse events and one grade 3 skin rash. Dose reduction was required in one patient (10%). Conclusions: Bevacizumab plus erlotinib is clinically active and well tolerated in heavily pre-treated patients with RMC and should be considered a viable salvage strategy for this lethal disease.

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