bluuebunny/crossref_metadata_2025_split huggingface dataset:
Weekly (QW) epoetin alfa (EPO) in prostate cancer (PC) patients (pts) with anemia not receiving chemotherapy (CT) or radiation therapy (RT)
Authors: Shasha D. 
Published: March 2020

14634 Background: While EPO is widely used in the management of CT-related anemia, anemia in cancer pts may stem from causes other than CT. Tumor invasion of the bone marrow and cytokine-mediated inhibition of erythropoiesis are among the many disease-related causes of anemia in cancer. Data evaluating the use of EPO in pts not receiving CT or RT, particularly in specific tumor types, would be important information to healthcare providers. Methods: An open-label, prospective, non-randomized, multicenter pilot study was conducted to evaluate the efficacy and safety of EPO 40,000 U QW in anemic (hemoglobin [Hb] ≤ 11 g/dL) cancer pts not receiving CT or RT1. (Blood 2004;104:abstract 4223.) Treatment duration was up to 12 wks with a 4-wk post-treatment observation period. Primary efficacy endpoint was hematopoietic response during the treatment period (% of pts achieving a ≥ 1 or ≥ 2 g/dL Hb increase from baseline [BL]). Secondary endpoints included change from BL in quality of life as measured by the Linear Analog Scale Assessment (LASA). This is a retrospective subset analysis of PC pts (n = 24) enrolled in the prospective study. Results: For the safety population (all pts who received ≥ 1 EPO dose, n = 23), mean age was 71.4 ± 6.8 yrs; 21 (91.3%) had ECOG status of 0 or 1; and mean BL Hb was 10.4 ± 0.8 g/dL. Of 21 pts evaluated for efficacy, 17 (81.0%) achieved Hb increase from BL ≥ 2 g/dL, while 19 (90.5%) achieved ≥ 1 g/dL by wk 17/early withdrawal. EPO dose was increased in 5 (23.8%) pts (to 60,000 U for Hb increase < 1 g/dL after 4 wks) and held in 16 (76.2%) pts (due to Hb > 13 g/dL, with dosing resumed when Hb was ≤12 g/dL, at 30,000 U from 40,000 U or at 40,000 U from 60,000 U). Both Wk 9 and 17 LASA scores increased significantly from BL in all categories (Energy Level, Daily Activities, and Quality of Life; P < 0.001). 15 of 23 pts (65.2%) had at least one adverse event (AE); 4 (17.4%) pts had at least one serious AE. No clinically relevant thrombotic vascular events were noted. No pt received transfusion. 5 pts discontinued: 2 for AEs, 1 at pt request, and 2 at study sponsor request. Conclusions: This retrospective analysis suggests that EPO 40,000 U QW is safe and effective for treating anemia in PC pts not receiving CT or RT. [Table: see text]
Interstitial high dose rate (HDR) brachytherapy under local anesthesia for early stage prostate cancer
Authors: White D. , Mark R. , Anderson P. J. , Neumann T. , Nair M. 
Published: March 2020

14639 Background: Transrectal Ultrasound (TRUS) guided interstitial implant for prostate cancer using Low Dose Rate (LDR) and High Dose Rate (HDR) techniques has been reported with results comparing very favorably to external beam radiation therapy. TRUS interstitial implant of the prostate has been traditionally performed under general or spinal anesthetic in an operating room. We report our results with a technique performed under local anesthesia in a Department procedure room. Methods: Patients with T1 and T2 localized prostate cancer were judged to be candidates for TRUS guided interstitial implant. Results: Between 2002 and 2006, 248 TRUS guided prostate implants were performed under local anesthesia. Conscious sedation consisted of intravenous Morphine (12–22 mg) and Versed (6–14 mg), or intravenous Demerol (50–175 mg) and Versed (3–12 mg). Local anesthetic was given with a mixture of 1% Lidocaine, 0.25% Marcaine, 1:100,000 Epinephrine, and 4% Sodium Bicarbonate neutralizing solution (20–120 cc). Local anesthesia was given to a 5 × 5 cm perineal area to a depth of 10 cm under TRUS guidance. The implants were placed under mobile multi-plane prostate template (Radiation Therapy Products Prostate Template) guidance using from 3 to 4 planes, and 12 to 22 needles. Needle spacing was 1.0 cm. The implant procedure included sigmoidoscopy and cystoscopy. Median implant time was 45 minutes (range: 30 to 150 minutes). HDR treatment was given using the Nucletron afterloading system. The implant volume received 2,250 cGy in 3 fractions prescribed to the 100% Isodose line, given over 24 hours. Urethral dose points (12–16) were followed, and limited to ≤ 105% of the prescription dose. The procedure was well tolerated, with all patients having completed the procedure. One patient developed respiratory suppression, and required reversal with Narcan. He recovered uneventfully. Otherwise, there have been no acute complications to date. Conclusions: TRUS interstitial implant of the prostate under local anesthesia is feasible. Implant time and complications compare favorably to general or spinal anesthetic technique. No significant financial relationships to disclose.
Effectiveness of zoledronic acid for the prevention of bone metastases in high risk prostate cancer patients: A randomised, open label, multicenter study of the European Association of Urology (EAU) in cooperation with the Scandinavian Prostate Cancer Group (SPCG) and the Arbeitsgemeinschaft Urologische Onkologie (AUO). An initial report of the “ZEUS” study
Authors: Witjes W. , Tammela T. , Wirth M. 
Published: March 2020

14644 Background: Patients with advanced prostate cancer (PC) are at high risk of developing bone metastases resulting in clinically significant skeletal morbidity and debilitating bone pain. Zoledronic acid (ZA) significantly reduced the incidence and delayed the onset of skeletal complications and provided durable pain reduction compared with placebo in patients with PC metastatic to bone. Methods: We started a European study investigating the effect of ZA in the prevention of PC bone metastases in patients with high risk PC. This prospective, multi-centre, randomised, open-label study, the ZA EUropean Study (ZEUS), aims at randomising 1300 patients within 3 years in 13 European countries and Turkey. Patients are randomised for standard PC therapy plus 4 mg ZA intravenously every 3 months for a period of 48 months or standard PC therapy alone. Results: Presently, we have randomised 484 patients with a mean age of 67 years (range 45–86) in 13 countries. All patients had at least one of the following high risk prognostic factors: 281 (58%) patients had a PSA ≥ 20 ng/ml, 140 (29%) patients had lymphnode positive disease and 286 (59%) patients had a Gleason of 8–10. 124 (26%) patients had a PSA ≥ 20 ng/ml and a Gleason of 8–10; 60 (12%) patients had a PSA ≥ 20 ng/ml and N1 disease and 64 (13%) patients had a Gleason of 8–10 and N1 disease. 244 (50%) patients underwent a prior prostatectomy or radiotherapy with curative intent and 303 (63%) patients received hormonal treatment. The randomisation arms were equally distributed amongst prognostic groups, centres and countries. Conclusions: The ZEUS study is designed to evaluate if ZA can contribute in preventing or delaying bone metastases in high risk PC patients. Presently, the majority (59%) of patients have a Gleason of 8–10 or a PSA ≥ 20 ng/ml (58%) and they receive hormonal treatment (63%). Half (50%) of the patients underwent a prior prostatectomy or radiotherapy with curative intent. This is representative for the PC population that is at high risk for developing bone metastases. No significant financial relationships to disclose.
Clinical outcome of postchemotherapy salvage surgery for metastatic germ cell tumors in Japan
Authors: Kakimoto K. , Kinouchi T. , Ono Y. , Meguro N. , Maeda O. , Usami M. , Nonomura N. , Oka D. , Miki T. , Mizutani Y. 
Published: March 2020

14654 Background: Salvage surgery including retroperitoneal lymph node dissection (RPLND) following chemotherapy has been considered a critical component in the comprehensive management of advanced germ cell tumors (GCT). The objectives of this study were to determine the pathologic findings and clinical outcome of patients with metastatic GCT who underwent postchemotherapy salvage surgery. Methods: From 1980 to 2004, 157 patients with metastatic diseases underwent postchemotherapy salvage surgery at three institutions. Surgical resection was indicated in the presence of residual radiographic abnormalities. The cause-specific survival rate was calculated using the Kaplan-Meier method. Results: The histology of GCT was pure seminoma in 49 patients and non-seminoma in 108 patients. As first-line chemotherapy, 30 patients were treated with PVB (cisplatin, vinblastine and bleomycin) regimen, 107 patients with PEB (cisplatin, etoposide and bleomycin) regimen and 20 patients with other regimens. Salvage surgery was performed after first-line chemotherapy in 87 patients and after salvage chemotherapy in 70 patients. As salvage surgery, RPLND was performed in 135 patients, resection of pulmonary metastasis in 38, hepatotomy in 2 and resection of metastatic brain tumors in 3. The pathological findings at surgery were necrosis in 87 (55%) patients, mature teratoma in 34 (22%) and residual cancer in 36 (23%). Five of 36 patients with residual cancer performed salvage surgery in the state of marker positive. Of the 31 patients who had residual cancer with normalized marker, salvage surgery was performed after salvage chemotherapy in 11 patients. The sites of residual cancer were retroperitoneal lymph nodes in 34 patients, lung in 4, brain in 2 and liver in 1. The cause-specific 5-year survival rates for patients who had necrosis, mature teratoma and residual cancer were 95%, 96% and 68%, respectively. Conclusions: Residual cancer could not reliably be predicted or discriminated from necrosis or mature teratoma. Therefore, salvage surgery to remove postchemotherapy residual masses remains essential in the successful treatment of metastatic GCT. No significant financial relationships to disclose.
Phase I-II trial of irinotecan (CPT) and cisplatin (P) as concurrent chemo-radiotherapy (CCRT) for patients (pts) with primary local advanced cervical cancer (LACC): A KCOG 0328 trial
Authors: Ito K. , Kita M. , Hosokawa K. , Toyoda S. , Kozuki M. , Hayashi M. , Takata T. , Miyoshi Y. , Koshiba H. , Tabata T. 
Published: March 2020

15002 Background: Though CCRT based on P is now recommended in LACC, there is no standard regimen. We conducted a phase I-II trial of CPT and P as CCRT in pts with primary LACC. Methods: Eligibility criteria: histologically confirmed primary LACC as FIGO stage III to IVb by para-aortic lymphnode (PAN) metastasis, age 16–75 years, ECOG performance status <2, adequate bone marrow, hepatic and renal function, and written informed consent. Radiotherapy (RT) consisted of external beam 5040cGy in 28 fractions followed by single application brachytherapy, delivering 1800–2400 cGy to point A in 3–4 fractions. The doses of chemotherapy (CT) were set up as follows: dose level (DL) 0; CPT 20 mg/m2, P 30 mg/m2, DL1; CPT 25mg/m2, P 30 mg/m2, DL2; CPT 30 mg/m2, P 30 mg/m2, and the starting level was chosen DL1. CT was curried out weekly 5 cycles concurrently with RT. Toxicities were assessed according to NCI-CTC ver2.0J and responses were assessed according to RECIST. Results: So far 9 pts have been entered. The median age was 52 years (range 29 -73). All pts were FIGO stage IIIb and histrogically squamous cell carcinoma. Among the first 2 pts in DL1, 2 dose-limiting toxicities (DLT) were observed (delay of treatment due to grade 3 diarrhea and nausea) resulting in dose reduction to DL0. In the next 3 pts in DL0, no DLTs were observed and the study is ongoing as phase II. All pts were evaluable for response and toxicity. Eight complete (CR) and 1 partial response (PR) were seen at target region of cervix. But 2 pts showed progressive disease (PD) at non-target region of PAN, lung and liver, then overall response rate assessed by RECIST was 77.8% (CR 7, PD 2). Now the median follow up period is 16 months (range 6 -30). So far 2 pts of PD died and 3 pts relapsed. The median survival time is 10+ months (range 6+ -30+). Toxicity in DL0 was observed febrile neutropenia in 1 pt only. Conclusions: The CCRT with CPT and P in DL0 is feasible and shows promising activity in pts with primary LACC. No significant financial relationships to disclose.
Feasibility study of neoadjuvant chemotherapy (NAC) followed by interval debulking surgery (IDS) for stage III/IV ovarian, tubal and peritoneal cancers: Japan Clinical Oncology Group study JCOG0206
Authors: Onda T. , Kamura T. , Hirakawa T. , Kuzuya K. , Hatae M. , Iwasaka T. , Konishi I. , Katsumata N. , Fukuda H. , Yoshikawa H. 
Published: March 2020

15020 Background: Retrospective analyses revealed that survival of ovarian cancer patients treated with NAC followed by IDS was comparable with those treated by standard treatment starting with primary debulking surgery. The purpose is to assess the safety and efficacy of the NAC setting treatment and also to know whether we can accurately diagnose the cancer by imaging studies, cytologic findings and tumor markers without diagnostic laparoscopy (DLS). Methods: The study was performed as a multi-institutional non-randomized phase II trial. Eligibility included stage III/IV müllerian carcinoma (MC) such as ovarian, tubal and peritoneal carcinomas diagnosed by imaging studies (CT and/or MRI), cytology of ascites, pleural effusions or fluids obtained by tumor centesis, CA125 >200 U/ml and CEA<20 ng/ml. After study enrollment, DLS is performed to confirm tumor origin, histology and stage. Four cycles of combination of paclitaxel (175 mg/m2, 3h) and carboplatin (AUC 6) are administered as NAC, followed by IDS and additional 4 cycles of chemotherapy. Primary endpoint is proportion of clinical complete remission (% cCR) with CA 125<20 U/ml among all stage III/IV MC confirmed by DLS (expected % cCR of 40% and threshold % cCR of 20%). Major secondary endpoint is positive predictive value (PPV) of clinical diagnoses concerning origin, histology and stage (expected PPV>90%, then DLS will be omitted in the next phase III study). The planned sample size was 56 eligibles, which gives 10% or lower Bayesian posterior probability that PPV is < 90% in case of three false positives. Results: Fifty six patients were enrolled between Jan/2003 and Feb/2004. All patients had accurate pre-DLS diagnosis concerning origin and histology. In 53 (PPV 94.6%) of 56 patients, tumor stage was accurately diagnosed. Twenty nine (62%) of 47 patients who underwent IDS had complete resection without residual tumors. Nineteen (%cCR 36%) among 53 patients with stage III/IV MC achieved cCR at completion of planned treatment. Conclusions: NAC starting without DLS followed by IDS for advanced MC is a promising treatment to be compared with the current standard treatment in a phase III study. [Table: see text]
Survival and prognostic factors in patients with epithelial ovarian cancer receiving paclitaxel and carboplatin as first-line chemotherapy in Japanese women: A multi-center retrospective study
Authors: Kajiyama H. , Kikkawa F. , Kawai M. , Mizuno K. , Kobayashi I. , Kinoshita Y. , Matsuzawa K. , Kamiya N. , Inoue T. , Sakakibara T. 
Published: March 2020

15022 Background: The aim of this retrospective study was to re-evaluate, multi-analytically, survival and prognostic factors of patients with epithelial ovarian cancer (EOC) receiving the combination of paclitaxel and carboplatin (PC). Methods: Between 1/00 and 12/04, a total of 335 cases with EOC of FIGO stage I-IV are registered in a multi-institutional series. All patients received cytoreductive surgery and combination chemotherapy of paclitaxel 180 mg/m2/3 hr and carboplatiion AUC = 5 for a total of 6 cycles. We retrospectively analyzed progression-free survival (PFS) and overall survival (OS) of these patients by stratification of assumable several prognostic factors and second-line regimen. Survival probabilities were estimated by Kaplan-Meier methods, and prognostic factors for survival were evaluated by a COX proportional hazard model. Results: Median age was 54 ± 11 years (range 9–81). The 3-, 4- and 5-year OS in patients was 67.0%, 53.9% and 50.6%, respectively. In a COX analysis, FIGO stage, histological type and residual tumor (2 cm < vs. 2 cm >; P = 0.0007, HR; 2.4, 95% CI = 1.4–4.0) were found to be independent significant factors for OS. The stratification analysis revealed that stage III-IV patients with clear cell and mucinous carcinoma have poorer prognosis than those with other histological types ( Table ). In contrast, no differences in histological grade (G1 vs. G2; P = 0.82, HR; 0.9, 95% CI = 0.5–1.6, G1 vs. G3; P = 0.65, HR; 0.9, 95% CI = 0.4–1.6) and kinds of second-line regimen were noticed for PFS and OS. Conclusions: Optimal surgical debulking, clinical stage, and histology appear to be important prognostic factors of survival in patients with EOC. This retrospective study suggests that PC may still have an impact on outcome. However, further strategy will be needed for improving survival of mucinous and clear-cell type EOC, especially with advanced stage. [Table: see text] No significant financial relationships to disclose.
Results of invasive cervical cancer patients undergoing inadvertent hysterectomy followed by salvage radiotherapy
Authors: Goel A. , Goel V. , Singh J. K. 
Published: March 2020

15034 Background: Ca cervix is the leading gynecologic malignancy in India. Conventional treatment consists of radical hysterectomy or primary radiotherapy. Due to inadequate preop workup, invasive ca cervix has been incidentally found in surgical specimens after simple hysterectomy. Extrafascial hysterectomy is not curative as paracervical, paravaginal soft tissues & vaginal cuff are not removed. It is technically difficult to perform adequate radical surgery after a previous simple hysterectomy. It is critical that these patients receive postop RT immediately after surgery; otherwise the prognosis is much worse. Methods: Retrospective analyses of 68 patients of ca cervix referred to our Institute after simple hysterectomy for presumed benign or preinvasive cervical disease was done. The median age was 44 yrs (35–65). 18 pts (26.5%) were pre menopausal while 50 (73.5%) were post menopausal. Exact postop staging was not possible; however 40 pts (59%) had residual growth at vault, 4 had involvement of vagina and in 18 cases parametrial infiltration was evident. Postop USG showed median tumor size of 4.4 cm, hydronephrosis in 17.6% & bladder infiltration in 5.8% pts. Histopathology was squamous cell carcinoma in 97% cases. Results: All patients were treated with EBRT to whole pelvis (dose 50 Gy/25 Fr to 50.4 Gy/28 Fr) over 5-weeks, followed by central vaginal surface HDR brachytherapy (Dose 21 Gy/3 Fr). At an average follow up of 18 to 24 months post RT residual disease was present in 2 (2.9%), local recurrence in 6 (8.6%), scar recurrence in 2 (2.9%) and distant failures in 4 patients (5.8%). Radiation proctitis developed in 2, SAIO in 2, RVF in one and VVF in one patient. All local and distant failures were seen in patients with residual disease before starting RT. Poor response to RT was seen in patients elder than 40 years and when OTT was more than 75 days. No significant correlation was seen between local response rate and type or grade of tumor. Conclusion: Survival for patients with no residual cancer after simple hysterectomy is favorable; & poor for those with gross disease at the start of post hysterectomy treatment. EBRT combined with one or two fractions of intravaginal brachytherapy in the immediate postop period can achieve satisfactory disease control. No significant financial relationships to disclose.
Efficacy of a gemcitabine based multiagent chemotherapy regimen for advanced uterine sarcomas
Authors: Singhal P. K. , Sharma S. , Benitez M. , Odunsi K. , Lele S. 
Published: March 2020

15047 Background: Advanced stage uterine sarcomas (US) have poor prognosis. Active agents in US are doxorubicin, cisplatin and ifosfamide, with response rates (RR) of 25%, 19%, and 17% respectively. Given the poor response, there remains a need for other drugs. Gemcitabine has shown activity in soft tissue sarcomas. In trials with all subtypes of sarcomas, RR observed with single and multiagent schedules are ranging from 3 to 53%. There is scarce data on the use of gemcitabine in US. Aim of our study was to determine the clinical activity of gemcitabine based regimen in patients with US. Methods: From 2002–2005, data from11 chemotherapy naïve patients diagnosed with advanced stage US was reviewed who were receiving gemcitabine/ifosfomide/platinum (GIP) combination chemotherapy regimen in an adjuvant setting after TAH and surgical staging. Ifosfomide 2gm/m2 and Platinum 20 mg/m2 intravenously on days 1, 2 and 3. Gemcitabine 800 mg/m2 intravenously was administered on day 1 of a 28-day cycle. Results: Eleven pts were treated, all stages III and IV. The median age was 49 years. There were 6 carcinosarcomas, 4 LMS, and 1 ESS. Performance status was 0 (6 pts), 1 (5 pts). Four pts (36%) had undergone prior radiotherapy. The site of measurable disease in 10 pts (91%) was in the pelvis. The median number of GIP cycles received per pt was 6 (range 1–9). There were no treatment-related deaths. Hematologic toxicities of > Grade 3 were seen in 82% of pts and consisted of leukopenia and anemia. 36% of pts had an episode of febrile neutropenia. Neurotoxicty (Grade 3 in 2 pts), nausea (Grade 1/2 in 6 pts), and fatigue (Grade 1/2 in 7 pts) were observed. Three (27%) complete responses were observed, four pts had a partial response (36%), for an overall RR of 63%. Four pts had progression of disease (36%). Of the 7 pts demonstrating a response, 4 had previously been irradiated and 3 had not, such that the RR in those previously irradiated was 4/4 = 100% versus 3/7 = 43% in those not previously irradiated. Conclusions: The combination of GIP is well-tolerated and seems to be active in US, yielding RR higher than seen with single agent chemotherapy agents. Pts that received previous adjuvant radiation demonstrated the best responses to this regimen. A randomized trial is needed to evaluate the true value of this regimen in advanced stage US. No significant financial relationships to disclose.