bluuebunny/crossref_metadata_2025_split huggingface dataset:
Postoperative LV5FU2 combination chemotherapy in patients with curative resected advanced gastric cancer
Authors: Lee H. , Lee K. , Park E. , Hwang I. , Jang J. , Lee S. 
Published: August 2020

e15660 Background: To illuminate the effect and toxicity of fortnightly low-dose leucovorin(LV) and fluorouracil(5FU) bolus plus continuous infusion(LV5FU2) postoperative chemotherapy(adjuvant) in patients with curative resected, advanced gastric cancer. Methods: Total 40 patients were enrolled in this study. All patients received LV 20mg/m2(bolus), 5FU 400mg/m2(bolus), 5FU 600mg/m2(24-hour continuous infusion) on day 1, 2, 15, and 16, every 4 weeks(LV5FU2), total 6 cycles. Results: Postoperative chemotherapy was initiated median 19 days after surgery. Total of 238 cycles were administered and median follow-up was 602 days. The median disease-free survival time was 728 days (95% CI, 411∼1045) and 2-year overall survival was 77%. Relapses were reported in 18 (45%) of the patients : Two of 9 patients relapsed in stage IIIA (22.2%), seven of 12 patients relapsed in stage IIIB (58.3%) and nine of 17 patients relapsed in stage IV (52.9%). They were all distant relapsed. Eight patients died. 7 patients died as a result of cancer progression and 1 patient suicided while receiving palliative chemotheraphy for cancer relapse. The grade 3∼4 toxicity of neutropenia 8.4% and anemia 0.4%, neutropenic fever 0.4% were observed. Conclusions: Postoperative LV5FU2 adjuvant chemotherapy is effective and tolerable for the patients with curative resected, advanced gastric cancer. No significant financial relationships to disclose.
A phase I/II safety and efficacy study of intratumoral light-activated drug therapy using talaporfin sodium in patients with inoperable hepatocellular carcinoma
Authors: Wang S. , Keltner L. , Winship J. , Lee W. 
Published: August 2020

e15684 Background: Light Infusion Therapy™ (Litx™) consists of the light-activated drug, talaporfin sodium (LS11®; mono-L-aspartyl chlorin e6), activated by a single-use, disposable device with an array of light-emitting diodes (LEDs). We evaluated talaporfin in combination with the light source in a phase 1/2 safety and efficacy trial in patients with hepatocellular carcinoma (HCC). To the best of our knowledge, this is the first clinical study of light-activated drug therapy in patients with HCC. Methods: Patients had confirmed primary HCC, 1–3 liver lesions, an ECOG score of 0–2, and a life expectancy of at least 16 weeks. Prior treatment failure with locally ablative techniques was allowed. The light-activated drug used in the study was talaporfin, a semi-synthesized, water-soluble chlorin e6 derivative. The LED device used in this study was a 1.5 mm diameter linear array of LEDs with a 25 mm emitting length at a wavelength of 664 nm. Patients underwent image-guided percutaneous placement of 1–4 LED device(s) using either local anesthesia or conscious sedation. The LED devices were used in single lesions or in multiple lesions. Following intratumoral placement of the LED devices, patients received talaporfin at 1 mg/kg IV bolus. Delivery of light energy commenced 15 min to 1 hr following drug administration with a total illumination time of 2.8 hrs. Results: The enrolled study group consisted of 8 patients. All 8 patients completed the week 4 assessment and were evaluated for tumor response. One (12.5%) out of 8 patients in this study was reported to have a complete response at week 4. Five patients (62.5%) were reported to have stable disease, and another 2 patients (25%) showed progressive disease. During the study, 7 patients reported a total of 16 treatment-related adverse events. There were no treatment-related adverse events that were greater than grade 2. At 1 year post treatment, all patients were alive. Conclusions: The results from this phase 2 study demonstrated that the therapy was safe for the treatment of HCC. A subsequent randomized controlled phase 3 pivotal trial is nearing completion and is designed to prove efficacy in patients with inoperable HCC. [Table: see text]
p53 and its influence in adenocarcinoma stomach
Authors: Servarayan C. M. , Chandramohan A. , Datta D. , Manickavasagam K. 
Published: August 2020

e15685 Background: Gastric cancer is the second most common cause of the malignancy in the world after lung cancer. Various pathogenesis have been given for the adenocarcinoma, like mutation in the E-catherin gene, amplification of COX-2, HGF/ SF, VEGF; deletion of FHIT, APC, p53 but none have provided a definite target for treatment. Methods: This is a immunohistochemical prospective experiment study done on 76 cases of Gastric Adenocarcinoma.The location of the tumors were recorded as in the proximal stomach (fundus and body) and distal stomach (antrum, prepylorus, and pylorus). PAb1801 clonewas obtained from the ZYMED LABORATRIES, San Franscisco. A standardised immunohistochemical method was followed in this study. Results: p53 mutations were seen 41 out of 76 cases(53.95%). And 23 out of 41(56.09%) cases of p53 expression of the total mutated cases expressed p53 100%. 20 out of 36 cases (55.55%) of age below 60 yrs and 21 out of 40 cases (52.55%) of age above 60 yrs were p53 positive. 33 out of 60 (55%)of the males and 8 out of 16 (50%) females were reported of having gastric adenocarcinoma with p53expression. The histology of the tissue samples from the gastric adenocarcinoma patients had following relationship with the p53 immunoreactivity, 20 out of 37 cases(54.05%) of the well differentiated,7 out of 17 cases (41.18% )of the moderately differentiated, and and 13 out of 21 cases(61.90%) of the poorly differentiated gastric adenocarcinoma showed positive immunoreactivity. 15 out of 33 cases (45.45%)were localized to the proximal stomach and 30 out of 52 cases (57.69%)were localized to the distal stomach. 52.63 % of the non-mucinous type of gastric adenocarcinoma showed positive p53 immunoreactivity. Conclusions: The TP53 mutation is slightly more common in males than females, with greater occurrence in the late years of life. The mutation is more marked in the poorly differentiated gastric adenocarcinoma. The antral, pylorus,and the prepyloric parts of the stomach( the distal stomach) are more prone for mutated p53 induced adenocarcinoma. No significant financial relationships to disclose.
Carboplatin and fluoropyrimidine-based treatment for metastatic gastric and gastroesophageal junction cancer: A retrospective review of the Stanford experience
Authors: Kunz P. L. , de Bruin M. A. , Balise R. R. , Fisher G. A. , Ford J. M. 
Published: August 2020

e15686 Background: There is no single standard chemotherapy regimen for the treatment of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. At Stanford Cancer Center (SCC) we regularly use a regimen of carboplatin and 5- fluorouracil (CF) or carboplatin and capecitabine (CX) for the treatment of these patients. Methods: A single institution retrospective review of patients with metastatic gastric and GEJ adenocarcinoma treated with CF or CX was conducted. Patients received carboplatin AUC 6 on day 1 and either 5-FU at 200 mg/m2/day (via continuous IV infusion) or capecitabine at 1,000 mg/m2 po BID for 14 days, repeated every 21 days. Only patients treated at SCC who received ≥ 2 cycles of chemotherapy were included. Results: Fourty-five patients were identified. The majority (62%) were male. Median age at diagnosis was 66 years. Twenty-nine (64%) had gastric and 16 (36%) had GEJ cancers. Thirty-six patients (80%) were chemotherapy-naïve. Twenty-nine (64%) had poorly differentiated and 10 (22%) had moderately differentiated adenocarcinomas; 13 (29%) had signet ring features. The average number of cycles administered was 5.4; one possible treatment-related death (2%) was identified. Median time to progression was 4.9 months and median overall survival was 7.3 months. Conclusions: CF and CX are well tolerated and yield acceptable outcomes in high-risk metastatic gastric and gastroesophageal junction cancers. The tolerability allows for the addition of novel targeted agents in future studies. No significant financial relationships to disclose.
Stereotactic robotic radiosurgery for localized prostate cancer: Initial evaluation of acute toxicities
Authors: Ponsky L. E. , Lillibridge C. , Brindle J. , Zhang Y. , Wessels B. , Einstein D. B. 
Published: August 2020

e16006 Background: We evaluated the initial acute toxicities experienced by patients treated with cyberknife fractionated radiosurgery for low and low-intermediate risk prostate cancer. Methods: Twenty-two patients with low or low-intermediate risk prostate cancer (T2a, GG 3+3=6 or 3+4=7, PSA <10) were enrolled prospectively on an IRB approved protocol and treated the planning target volume (PTV)(prostate+5mm margin) with cyberknife fractionated radiosurgery to a dose of 36.25 Gy in 5 fractions (7.25Gy/fraction). The target volume included the prostate and seminal vesicles. PSA values, AUA symptom scores (AUA SS), and NCI CTC acute toxicities were analyzed prior to radiosurgery and at 1 month (N=16), 3 months (N=12) and 6 months (N=5)post-treatment. Results: Patients treated on study included 12 with GG 3+3=6 cancer and 10 with GG 3+4=7 cancer. Mean patient age was 66 years old (range 49–79). Mean pre-treatment PSA was 5.29 (range 0.64–9.36) declining to 3.44 (range 0.00–10.43) at 1 month post treatment, 1.99 (range 0.31–3.99) at 3 months post-treatment and 2.08 (1.05–3.13) at 6 months post-treatment. Mean pre-treatment AUA SS was 7 (range 0.–18) increasing to 12 (range 2–29) at 1 month post treatment, decreasing to 8 (range 2–17) at 3 months post-treatment and 11 (3–17). There were 5 grade 1 acute toxicities including (diarrhea, fatigue, mild urinary frequency, hemorrhoid and a rash) and 7 grade 2 toxicities including (bladder spasms, painful urinary, bowel irregularity, rectal pain, urethritis and numbness in the upper thigh), all grade 1 and 2 toxicities resolved within three months of treatment. The one patient with grade 2 thigh numbness was not thought to be study related toxicity. Two patients developed grade 3 toxicity. One developed bacteremia after the transrectal ultrasound guided placement of the fiducials, the infection completely resolved after treatment with antibiotics. One patient on Coumadin developed hematuria which resolved with conservative management. Conclusions: Cyberknife fractionated radiosurgery for patients with early stage prostate cancer appears to be safe on our early initial assessment.Continued evaluation and longer follow-up ongoing. [Table: see text]
Correlation of RRM1 expression in muscle invasive locally advanced urothelial cancer with age
Authors: Harshman L. C. , Bepler G. , Zheng Z. , Higgins J. P. , Allen G. I. , Tibshirani R. , Srinivas S. 
Published: August 2020

e16021 Background: RRM1, the regulatory subunit of ribonucleotide reductase, plays a role in DNA repair after chemotherapy damage and in gemcitabine metabolism. Prior studies demonstrated a survival benefit to high expression in resected early stage lung cancer and a trend toward longer time to progression with low expression in advanced bladder cancers treated with gemcitabine and cisplatin. We hypothesized that patients with resected locally advanced (T2–4NxM0) urothelial transitional cell carcinoma (TCC) whose tumors had higher RRM1 expression would have longer overall survival (OS). Methods: 84 radical cystectomy specimens with muscle invasive TCC were identified from existing tissue microarrays (TMAs) containing 343 specimens. The medical records of these patients were retrospectively reviewed to confirm pathology and stage. Presence of muscle invasion was required. Specimens were analyzed for RRM1 expression using AQUA. The median value of RRM1 was established a priori as the cutoff for high and low expression. Results: Median age of the patients was 69.3 years. There was near equal distribution of stages: 30%, 38%, and 32% for stage II, III, and IV respectively. The majority were high grade (99%) with no nodal involvement (69%). Median OS was 2.0 years (0–13.1). Median RRM1 expression was 1493.3. Degree of RRM1 expression did not correlate with OS, but when adjusted for age, adding an interaction term, high RRM1 expression in younger patients correlated with increased OS (p = 0.0278). Median OS for high expressors age <69.3 years was 6 years compared to 2.3 years for low expressors. 35% of patients less than 70 years were high expressors. Conclusions: Our results suggest that high RRM1 expression may be a prognostic factor for improved survival in locally advanced TCC patients less than 70 years old. These results deserve further study in a larger prospective analysis with disease-specific survival assessment and correlation with other possible prognostic genes such as ERCC1. [Table: see text]
Granulocyte macrophage: Colony stimulating factor (GM-CSF), ketoconazole, and mitoxantrone as second-line therapy in patients (Pts) with progressive hormone refractory prostate cancer (HRPC)
Authors: Doshi G. , Cen P. , Ramirez P. , Amato R. 
Published: August 2020

e16033 Background: A variety of docetaxel regimens have been tested in HRPC pts, yielding response rates between 38% - 69%. Docetaxel therapy has been widely used as first line therapy. Second line therapies, which are non - taxane based with comparable activities do not exist. This trial is built on the significant body of work which has demonstrated anti-tumor activity of GM-CSF, Ketoconazole and Mitoxantrone alone and in combination in pts with HRPC. The trial is designed to assess the combination of all three agents. Methods: No more than two prior chemotherapy regimens (one which contained docetaxel), progressive disease, and adequate marrow / organ function. Treatment consisted of: Ketoconazole daily 400mg po tid, GM-CSF subcutaneous 250mcg / m2 (14 days on/ 7 days off) and Mitoxantrone 12mg / m2 every 3 weeks (maximum cumulative dose of 140mg / m2), until either the completion of Mitoxantrone or maximum anti-tumor benefit. Pts continued Ketoconazole/ GM-CSF until disease progression. PSA was evaluated every 3 weeks and radiographic studies were performed every 9 weeks. Results: 31 pts were enrolled; 4 pts with PSA only, 9 bone only, 5 soft tissue only, and 13 bone and soft tissue. 2 pts withdrew from study due to toxicity. 8 pts had a PSA response of ≥ 50%, 5 pts had a PSA response of ≥ 80%, and 7 pts had a PSA response of ≥ 90%. 9 pts progressed. The majority of pts had stabilization of their bone and soft tissue involvement and 2 pts with nodal involvement demonstrated a radiographic CR. Significant adverse events included grade III/IV neutropenia, thrombocytopenia, and nausea. Median duration of treatment was 6.22 months (range 2 months - 20.5 months). Conclusions: GM-CSF, Ketoconazole and Mitoxantrone in combination demonstrate significant anti-tumor activity and reversible toxicity in pts who have failed prior docetaxel therapy. Information regarding PSA response, radiographic outcome and adverse event data will be presented. This data warrants further investigation such as a randomized phase II study. [Table: see text]
Prostate cancer screening practice among men age 75 and older: Results from a national survey
Authors: Hoffman K. E. , D'Amico A. V. 
Published: August 2020

e16034 Background: The U.S. Preventative Services Task Force recently recommended not to screen men aged 75 and older for prostate cancer. This study evaluated the use of prostate specific antigen (PSA) screening among men age 75 and older prior to this declaration. Methods: The study cohort comprised 718 men age 75 or older without a history of prostate cancer who responded to the 2005 National Health Interview Survey, representing an estimated 4.47 million non-institutionalized men annually. Univariable and multivariable logistic regression was used to determine factors associated with PSA screening. Results: Of the 718 men, 19.2 % were age 85 or older, 42.2% reported fair or poor health, 24% had two or more significant diseases and 10.9% were dependent in at least one instrumental activity of daily living (IADL). More than half (51.6%) underwent PSA screening within the previous two years. Men who reported poor health status (42.2 vs. 55.2%, p=0.005) and men who had difficulty with at least one IADL (37.4 vs. 53.3%, p=0.010) were less likely to have a screening PSA. After adjustment for age, race, education status, and physician access, poor health status (adjusted odds (AOR): 0.70, 95% CI (CI): 0.45 to 1.10; p = 0.119), two or more significant diseases (AOR: 0.78, CI: 0.48 to 1.27; p = 0.333) and difficulty with at least one IADL (AOR: 0.71, CI: 0.42, 1.20; p = 0.202) were not associated with the use of PSA screening. Of the 104 men likely to live for five years or less because of poor health, 35.0% underwent PSA screening. Conclusions: Health status, a predictor of life expectancy, should be considered when determining which men receive PSA screening. This would reduce the use of PSA screening in men unlikely to benefit. No significant financial relationships to disclose.
Cytokines and angiogenic factors in metastatic renal cell cancer: Association of pretreatment serum levels with survival
Authors: Montero A. J. , Diaz-Montero C. M. , Liu J. , Do K. , Millikan R. E. , Tannir N. M. 
Published: August 2020

e16036 Background: To correlate serum cytokine and angiogenic factor (CAF) levels and overall survival (OS) in metastatic renal cell cancer (mRCC) treated with interferon-alpha (IFN-α). Methods: Serum CAF levels were measured in 103 patients treated on a randomized trial with IFN-α 0.5 million units (MU) twice daily or 5 MU daily. Concentrations of 17 analytes including vascular endothelial growth factor (VEGFA) and several cytokines were determined by multiplex bead immunoassays or ELISA (basic fibroblast growth factor). We used proportional hazards models to evaluate the effect of CAF levels and clinical factors on OS. Results: Pretreatment serum interleukin (IL)-5, IL-12p40, VEGFA, and IL-6 levels, and Memorial Sloan-Kettering Cancer Center risk grouping were independently correlated with OS, with hazard ratios of 2.33, 2.00, 2.07, 1.82 and 0.39, respectively (concordance index = 0.69 for the combined model versus 0.60 for the CAF model versus 0.52 for the clinical model). Based on an index derived from these five risk factors (RF), patients with 0–2 RF had a median OS time of 32 months, versus 9 months for patients with 3–5 RF (p < 0.0001). Conclusions: Serum CAF profiling contributes to prognostic evaluation in mRCC and helps to identify a subset of patients with 20% 5-year OS. No significant financial relationships to disclose.
High response to docetaxel (D)/carboplatin (C) based chemotherapy as salvage therapy in patients with docetaxel-resistant metastastic hormone-refractory prostate cancer (HRPC)
Authors: Reuter C. , Ivanyi P. , Morgan M. , Ganser A. , Winkler T. , Fenner M. , Grünwald V. 
Published: August 2020

e16041 Background: Presently, there is no standard treatment for prostate cancer (PC) patients who are resistant to docetaxel therapy. While previous reports support the use of C in combination with D in these patients (pts), the optimal regime is still unknown. Methods: Metastatic HRPC pts with clinical and/or radiographic evidence of progression while on docetaxel were included in our retrospective analysis. Between February 2005 and December 2008, 30 pts received treatment with C AUC 5 q3wks in combination with D 75 mg/m2 q3wks or D 35 mg/m2 d1, d8, d15 q4wks. All pts were assessed for PSA response and clinical outcome. Results: 27 pts were evaluable for response. Median age was 69 years (range 56–77) and median baseline performance status was ECOG 1 (range 0–2). The median number of prior therapies was 1 (range 1–3) with a median of 7 cycles of D therapy (range 3–34) administered. Median PSA at baseline was 297.15 ng/ml (range 12.33–6,446). Serum chromogranin A and neuron-specific enolase (NSE) were elevated in 24/24 and 8/25 cases, respectively. The median follow-up was 8.9 months (range: 0–38) with a median number of 6 cycles DC administered (range: 2–35). PSA declines of ≥50% (= PSA-response) was achieved in 14 of 27 pts (52%, 95% C.I. 0.32, 0.71) and PSA stabilization in 9 pts (33%). 4 pts (15%) progressed without PSA response. 6 PSA responders had a PSA reduction of >90%. The median duration of PSA response was 20.7 wks (95% C.I. 18.4, 59 wks). TTP was significantly longer in PSA responders vs. PSA non-responders (64.7 wks vs 15 wks, p<0.0001). 10 of 16 pts with measureable disease were evaluable for response. 3 of 6 PSA responders had a PR and 3 SD, while 2/4 pts with PSA non-response had PD and 2 SD. At the time of analysis, 2 PSA responders and 7 PSA non-responders have died. Median OS of all patients was 69.7 weeks with 79.9 wks for PSA responders vs. 38 wks for PSA non-responders (p=0.0034). The most common grade 3/4 toxicities were neutropenia in 42%, anemia in 23% and thrombocytopenia in 15% of pts. 17 of 30 pts had blood transfusions due to anemia. Conclusions: This retrospective analysis supports the usefulness of C plus weekly D chemotherapy as ≥second-line chemotherapy in docetaxel-resistant PC patients. No significant financial relationships to disclose.
Correlation of serum interleukin-6 (IL-6) levels and clinical outcome in hormone-independent (HI) prostate cancer (PC) patients (PTS) treated with docetaxel
Authors: Visa L. , Pineda E. , Farrus B. , Codony-Servat J. , Filella X. , Albiol S. , Martinez A. , Domingo-Domench J. M. , Gascon P. , Mellado B. 
Published: August 2020

e16044 Background: IL-6 acts as an autocrine and paracrine growth factor in PC, linked to HI progression. We previously reported preliminary data on the correlation of serum IL-6 and D response in metastatic HI PC pts. We present here a larger group of pts tested to asses the clinical relevance of IL-6 in these pts. Methods: Pts with HIPC treated with D were prospectively tested for IL-6 levels by ELISA before D. Prostate-specific antigen (PSA) response, time to PSA progression, overall survival (OS) and PC specific survival (SpS) were analyzed. Evaluated variables were age, performance status, PSA, Gleason, number (n) of D cycles, time to HI progression, presence of visceral metastasis, n of bone metastasis, hemoglobin, lactate deshydrogenase and alkaline phosphatase. Results: Seventy-two pts were included. At the time of the analysis 5 pts had died from non-PC related causes, two from treatment toxicity and 29 (40%) from PC. Mean of age was 69 ± 7 years. Median baseline IL-6 level was 14 pg/ml (range 0.1–1100). Thirty-five pts (49 %) had IL-6 levels > 14 pg/ml. IL-6 > 14 pg/ml correlated with lower D response (13 % vs 40%, p= 0.039); lower time to PSA progression (4 months vs 6, p=0.023); lower OS (10 months vs 25, p= 0.001) and lower PC SpS (12 months vs 26, p= 0.001), in contrast to pts with IL-6 ≤ 14pg/ml. In the multivariate analysis, serum IL-6 (p=0.002), n of bone metastasis (p=0.008) and n of D cycles (p=0.002), were independent prognostic factor for OS and PC SpS. Conclusions: High serum IL-6 correlates with an adverse clinical outcome of pts with HIPC treated with D. IL-6 determination may be a potential tool to select patients for D-based or targeted therapies. FIS ( PI070388 ) No significant financial relationships to disclose.