scholarly journals Outcome of Varicocelectomy with Different Degrees of Clinical Varicocele in Infertile Male

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
S. V. Krishna Reddy ◽  
Ahammad Basha Shaik ◽  
S. Sailaja ◽  
M. Venkataramanaiah
Keyword(s):  
Pregnancy Rate ◽  
Sperm Motility ◽  
Postoperative Period ◽  
Sperm Concentration ◽  
Testicular Volume ◽  
World Health ◽  
Grade 3 ◽  
One Year ◽  
Infertile Patients

Aim. To evaluate the prevalence and effect of varicocele repair on sperm motility, sperm concentration, testicular volume, and pregnancy rate in different degrees of clinical varicocele. Material and Methods. The case records were retrospectively evaluated for 482 infertile patients with varicocele who underwent varicocelectomy from December 2008 to December 2013. Semen analysis of patient at preoperative and 3-, 6-, and 12-month postoperative period was done. Varicocele was graded as per the World Health Organization grading (WHO 1993) system and included in the study. Testicular volume was noted by ultrasonography in pre- and postoperative period in one-year follow-up. Pregnancy rate was calculated at 3, 6, and 12 months of follow-up. Results. Significant differences were seen in sperm motility and concentration of patients with Grade 3 varicocele as compared with Grade 1 and Grade 2 varicocele. Significant increase in testicular volume was present after one year in Grade 3 varicocele in the postoperative period. There was significant correlation between the testicular volume and the sperm concentration. Percentage of spontaneous pregnancy in 1 year after varicocele treatment was 32 to 41% of cases. Conclusion. Varicocelectomy significantly improved sperm motility, concentration, and testicular volume. There were 32 to 41% of infertile patients who achieved pregnancy spontaneously.

scholarly journals Correlation Between Ultrasonic Testicular Volume and Seminal Fluid Analysis in Men with Infertility

2021 ◽  
Vol 3 (1) ◽  
pp. 103-107
Author(s):  
Sadiq Abu ◽  
Hadijat O. Kolade-Yunusa ◽  
Terkaa Atim ◽  
F. Ehimatie Obakeye ◽  
Nuhu K. Dakum
Keyword(s):  
Sperm Motility ◽  
Teaching Hospital ◽  
Seminal Fluid ◽  
Sperm Concentration ◽  
Testicular Volume ◽  
Seminiferous Tubules ◽  
Testicular Function ◽  
Semen Volume ◽  
Significant Difference ◽  
The Mean

Background: Infertility is a major cause of marital disharmony in Nigeria because of the high premium placed on childbearing. Unfortunately, the blame is on the woman most times in Nigeria. Seminiferous tubules comprise 80-90% of testicular mass. Thus, the testicular volume is an index of spermatogenesis. Therefore, accurate testicular volume will help in assessing testicular function if there is no obstruction. This study was conducted to evaluate the correlation between testicular volume, measured by ultrasound and conventional sperm parameters (semen volume, sperm concentration, sperm motility and sperm morphology) in men with infertility presenting to Urology Division, University of Abuja Teaching Hospital, Gwagwalada Abuja. Methodology: This was a descriptive cross sectional study, male subjects with infertility presenting to University of Abuja Teaching Hospital were recruited into the study. The testicular volume of all the subjects was measured by ultrasonography. The semen samples were collected by the process of masturbation on day five of sexual abstinence and analyzed according to WHO criteria 2010. Collated data were analyzed using SPSS version 20.0. P-value<0.05 was taken as statistically significant. Results: The average total testicular volume (TTV) of men with infertility was 19.83 ml while mean testicular volume (MTV) was 10.24 ml. There was a statistically significant difference between MTV and semen volume (r=0.391, p=0.000), and sperm concentration (r=0.639, p=0.000). There was a weak and insignificant correlation between MTV and sperm motility and MTV and morphology (r=0.216, p=0.055 and r=0.076, p=0.502) respectively. Linear regression analysis showed significant impact of MTV (P<0.001) on sperm concentration with a critical MTV of ≤10ml.0 indicating poor testicular function (severe oligospermia) Conclusion: The mean ultrasonic testicular volume in men with infertility in this study was 10.24ml and there was a significant positive correlation of MTV with semen volume and sperm concentration. Although, there was correlation of MTV with sperm motility and morphology, this was not significant. The critical mean ultrasonic testicular volume indicating poor testicular function (severe oligospermia) was found to be 10ml. This study has shown that the mean ultrasonic testicular volume can be a pointer to semen volume and sperm concentration in evaluating men with infertility.

Hemiarthroplasty proximal femoral endoprostheses following tumour reconstruction

2018 ◽  
Vol 100-B (1) ◽  
pp. 101-108 ◽  
Author(s):  
J. D. Stevenson ◽  
V. S. Kumar ◽  
G. L. Cribb ◽  
P. Cool
Keyword(s):  
Revision Surgery ◽  
Pathological Fracture ◽  
Bone Erosion ◽  
Bone Tumour ◽  
Early Migration ◽  
Medial Migration ◽  
Primary Bone ◽  
Grade 3 ◽  
One Year

AimsDislocation rates are reportedly lower in patients requiring proximal femoral hemiarthroplasty than for patients undergoing hip arthroplasty for neoplasia. Without acetabular replacement, pain due to acetabular wear necessitating revision surgery has been described. We aimed to determine whether wear of the native acetabulum following hemiarthroplasty necessitates revision surgery with secondary replacement of the acetabulum after proximal femoral replacement (PFR) for tumour reconstruction.Patients and MethodsWe reviewed 100 consecutive PFRs performed between January 2003 and January 2013 without acetabular resurfacing. The procedure was undertaken in 74 patients with metastases, for a primary bone tumour in 20 and for myeloma in six. There were 48 male and 52 female patients, with a mean age of 61.4 years (19 to 85) and median follow-up of two years (interquartile range (IQR) 0.5 to 3.7 years). In total, 52 patients presented with a pathological fracture and six presented with failed fixation of a previously instrumented pathological fracture.ResultsAll patients underwent reconstruction with either a unipolar (n = 64) or bipolar (n = 36) articulation. There were no dislocations and no acetabular resurfacings. Articular wear was graded using the criteria of Baker et al from 0 to 3, where by 0 is normal; grade 1 represents a narrowing of articular cartilage and no bone erosion; grade 2 represents acetabular bone erosion and early migration; and grade 3 represents protrusio acetabuli. Of the 49 patients with radiological follow-up greater than one year, six demonstrated grade 1 acetabular wear and two demonstrated grade 2 acetabular wear. The remainder demonstrated no radiographic evidence of wear. Median medial migration was 0.3 mm (IQR -0.2 to 0.7) and superior migration was 0.3 mm (IQR -0.2 to 0.6). No relationship between unipolar versus bipolar articulations and wear was evident.ConclusionHemiarthroplasty PFRs for tumour reconstruction eliminate joint instability and, in the short to medium term, do not lead to native acetabular wear necessitating later acetabular resurfacing. Cite this article: Bone Joint J 2018;100B:101–8.

scholarly journals What are the Risk Factors for Worse Outcomes of Meniscus Surgery in 23-39-Year-Old Patients Ligamentously Stable Knees?

2020 ◽  
Vol 8 (7_suppl6) ◽  
pp. 2325967120S0046
Author(s):  
◽  
Megan Flynn ◽  
Anthony Egger ◽  
Yuxuan Jin ◽  
Elizabeth Sosic ◽  
...  
Keyword(s):  
Risk Factors ◽  
Young Adult ◽  
Patient Reported Outcomes ◽  
Meniscal Repair ◽  
Patient Specific ◽  
Lower Baseline ◽  
Patient Reported ◽  
Grade 3 ◽  
One Year

Objectives: Meniscus tears are a common and significant source of knee dysfunction in active young adult patients, and no high-quality prospective cohort or RCTs studies exist evaluating patient-reported outcomes in patients in this age group with ligamentously stable knees. Our objective was to identify patient-reported outcomes and patient-specific risk factors from a prospective cohort with a minimum of one-year follow-up following meniscal repair or excision in patients with ligamentously stable knees. We hypothesized that both groups would have significant improvement in outcomes; patients undergoing meniscal repair would have a higher reoperation rate; and articular cartilage injuries, subsequent knee surgery, and certain demographic characteristics would be significant risk factors to inferior outcomes at one year. Methods: Between February 2015 and December 2017, ligamentously stable meniscal procedures were enrolled and prospectively followed using the outcomes management evaluation system (OME) at Cleveland Clinic. Patients aged 23-39 preoperatively completed a series of validated outcome measurements including the Knee Injury and Osteoarthritis Outcome Score for both Pain (KOOS Pain) and Quality of Life (KOOS QoL). At the time of surgery, physicians documented all intra-articular findings, treatment, and surgical techniques utilized. Patients were followed at minimum of 1-year postoperatively through the OME platform and asked to complete the same outcome instruments done at baseline as well as a question designed to evaluate the Patient Acceptable Symptom State (PASS). The incidence and details of any subsequent knee surgeries were also obtained. Multivariable regression analysis was used to identify significant predictors of outcomes. Results: A total of 371 patients aged 23-39 underwent meniscus excision or repair during the study period. One hundred ninety-four met inclusion criteria, and one-year follow-up was obtained on 72% (n = 139) of the cohort (67% male; median age 32). Both KOOS Pain and KOOS QoL improved significantly at one-year for the entire cohort. Fourteen percent of the cohort (9% on the ipsilateral knee, 5% on the contralateral knee) underwent subsequent surgery at a minimum of one-year postoperatively. The patient-specific risk factors for worse one-year outcomes included preoperative baseline mental capacity score (VR-12 MCS), lower baseline KOOS QoL score, and the intraoperative finding of any grade 3 or 4 chondral changes. Conclusion: Young adult patients with ligamentously stable knees undergoing meniscal surgery have significantly improved patient-reported outcomes regardless of excision or repair; however, 14% of patients underwent additional knee surgery at a minimum of one-year postoperatively. The risk factors for worse outcomes include lower baseline mental health score, lower baseline KOOS QoL score, and any grade 3 or 4 chondromalacia scene.

Outcome of Patients Age 60 and Over with Acute Lymphoblastic Leukemia (ALL) Treated with a Modified Pediatric Protocol

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3962-3962 ◽  
Author(s):  
Susan Kao ◽  
Wei Xu ◽  
Vikas Gupta ◽  
Mark Minden ◽  
Andre Schuh ◽  
...  
Keyword(s):  
Overall Survival ◽  
Side Effects ◽  
Lymphoblastic Leukemia ◽  
Maintenance Phase ◽  
Induction Phase ◽  
Cns Prophylaxis ◽  
Grade 3 ◽  
One Year ◽  
The One

Abstract Acute lymphoblastic leukemia (ALL) in patients over age 60 years is a poor prognosis disease with complete remission rate of 50–60% and median overall survival of less than a year. Between July 2004 and June 2007, we treated 17 elderly patients with newly diagnosed ALL with a modified pediatric protocol that included a remission induction phase, a CNS prophylaxis phase with intrathecal chemotherapy × 4, a 21-week intensification phase (7 cycles × 3 weeks each), and a 72-week maintenance phase. Induction chemotherapy consisted of vincristine 2 mg weekly × 3, doxorubicin 30mg/m2 × 2 doses, methotrexate 40mg/m2 × 1, asparaginase 12,000/m2 U × 1, and dexamethasone 40mg/day × 8 doses; BCR-ABL+ patients received imatinib mesylate 400 mg daily × 16 days instead of asparaginase. The intensification phase consisted of vincristine 2 mg × 7 doses, doxorubicin 30mg/m2 × 7 doses, asparaginase 6000 U/m2 weekly × 21 doses, 6-mercaptopurine 14/21 days, and dexamethasone 6 mg BID × 5/21 days. BCR-ABL+ patients received imatinib 400 mg daily × 14/21 days instead of asparaginase. Maintenance was the same as intensification except that no asparaginase was given. The median age was 66 years (range 60–78 years). Seven patients (41%) were BCR-ABL+ and four (24%) were pre-B with WBC &gt; 30. Major side effects during the induction phase included infection (71%), hyperglycemia requiring insulin (24%), and cardiac toxicity (18%). The complete remission (CR) rate was 71% with an induction mortality of 29%. Of the five induction deaths, four were due to bacterial sepsis or pneumonia, and one was due to tumor lysis syndrome. CNS prophylaxis was well-tolerated except in one patient who required IV hydration for nausea/vomiting. Eleven patients proceeded to intensification. Major side effects during the intensification phase included infections (64%), peripheral neuropathy (64%), thrombosis (27%), and grade 3 nausea/vomiting (27%). Two patients required hospitalization during the intensification phase; there was one myocardial infarction and one acute pancreatitis. Eleven patients proceeded to the maintenance phase; major side effects during maintenance included infections (36%) and grade 3 peripheral neuropathy (18%). Two patients (17%) have relapsed, both during early maintenance phase; both had had a number of dose modifications and delays during intensification. The one year overall survival (OS) was 71% and the median OS has not been reached. After a median follow-up duration of 17 months (range 9–40 months), the median relapse-free survival (RFS) of the CR patients has not been reached; the one year RFS was 82%. These results show that administering a modified pediatric protocol to patients over age 60 years with ALL is feasible with an improved CR rate than generally reported. The OS and RFS also compare favorably to previously reported results, although further follow-up is required. However, induction mortality was high, and infectious complications persisted throughout the entire course of induction and intensification, though much diminished during the maintenance phase. Accrual to the protocol is continuing.

Plasmablastic Lymphoma Is Curable The HAART Era. A 10 Year Retrospective By The AIDS Malignancy Consortium (AMC)

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1801-1801 ◽  
Author(s):  
Ariela Noy ◽  
Amy Chadburn ◽  
Shelly Y. Lensing ◽  
Page Moore
Keyword(s):  
Initial Diagnosis ◽  
Stage I ◽  
Plasmablastic Lymphoma ◽  
High Dose ◽  
Refractory Disease ◽  
Newly Diagnosed ◽  
Grade 3 ◽  
One Year ◽  
Experienced Grade

Abstract Background The highly aggressive plasmablastic lymphoma (PBL), originally described almost exclusively in HIV+ patients, was nearly uniformly fatal in the pre-HAART era. We hypothesized that aggressive chemotherapy and HAART could result in cures. Methods We retrospectively analyzed baseline characteristics, treatment patterns and outcomes of patients (pts) with PBL treated at multiple centers within the AIDS Malignancy Consortium (AMC). HIV positivity was not required. 19 confirmed PBLs from 9 national AMC sites diagnosed between 1999 and 2008 were evaluated. Results 17/19 patients (pts) with confirmed PBL were HIV+. Data was captured at initial diagnosis on 12 pts (all HIV+) and 7 with relapsed/refractory disease (5 HIV+). HAART status at PBL initial diagnosis was 33% on, 58% off, and unknown 8%. Median CD4 count 110 (range 4-658). First line chemotherapy was given to 10/12 (83%) newly diagnosed patients with stage I/II (6) vs III/IV(6) disease. This was CHOP(4), CDE (1), EPOCH (2) and EPOCH with high dose methotrexate and zidovudine (2). Second line therapy was given to 5/7 relapsed/refractory patients with stage I (1) vs Stage III/IV (5) disease and a median CD4 83 (range 10-202): EPOCH alternate HD Mtx+AZT (n=1); Hyper-CVAD (n=2); High dose Mtx + AZT (n=1); VACOP-B(n=1). One pt underwent BEAM based autologous stem cell transplant. For both groups combined, 6 patients experienced grade 3/4 toxicity. Febrile neutropenia was the most common grade 3/4 toxicity (4 patients) followed by thrombocytopenia (3 patients). One patient with refractory disease experienced grade 5 toxicity. For the 12 newly diagnosed patients, 8 patients were alive at last follow-up and 4 had died. Median follow-up for survivors was 73 (range, 40-165) weeks. One-year survival was 66.7% (SE, 13.6). See Figure 1. For the 7 relapsed/refractory patients, 2 patients were alive at 24 and 54 weeks, and 1 was lost to follow-up. One-year survival was 53.6% (SE, 20.1%). Conclusions In the HAART era, aggressive treatment of PBL can result in significant survival times. However, determination of the superior treatment regimen could not be determined from this small patient sample. CTSU 9177 is prospectively studying PBL with EPOCH. Disclosures: No relevant conflicts of interest to declare.

A pilot study of myeloablative (MA) autologous stem Cell (Auto SCT) followed by reduced intensity (RI) allogeneic transplantation (AlloSCT) in children with relapsed/refractory(R/R) Hodgkin’s disease (HD)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 20007-20007
Author(s):  
M. Bradley ◽  
L. Baldinger ◽  
M. Bhatia ◽  
J. Garvin ◽  
D. George ◽  
...  
Keyword(s):  
Allogeneic Transplantation ◽  
Grade Ii ◽  
Refractory Lymphoma ◽  
Grade 3 ◽  
One Year ◽  
Involved Field ◽  
Involved Field Radiotherapy ◽  
Median Cell

20007 Background: Allo SCT may benefit patients with R/R HD by providing a graft vs lymphoma effect. Peggs et al (Lancet 2005) demonstrated durable engraftment and reduced non relapse mortality (NRM) in HD pts post RI Allo SCT. Carella et al (JCO2000) and Gutman et al (BMT2005) demonstrated the success of MA Auto SCT followed by RI AlloSCT in adults with refractory lymphoma. We investigated the feasibility of MA Auto SCT followed by RI Allo SCT in children with R/R HD. Methods: MA conditioning prior to AutoSCT was CTX 1,500 mg/m2 x 4 d, BCNU 100 mg/m2 x 3d, VP-16 800 mg/m2 x 3d. AlloSCT conditioning was fludarabine 30 mg/m2 x 5d, busulfan 3.2 mg/kg x 2d, and R ATG 2 mg/kg x 4d (unrel. donor). CD20+ patients received rituximab (375 mg/m2/wk x4) and all pts received involved field radiotherapy (IFRT). Results: Ten pts have enrolled, 2 pts did not proceed (parental withdrawal) to RI AlloSCT (Donors: 1 MRD, 2 MUD, 5 UCB). Median time to RI AlloSCT after MA Auto SCT was 142 d (97–219). The median cell dose was 3.43 x 107 TNC/kg for UCB grafts (n=5). Engraftment was achieved at a median of 20.5 d for PMN and 46.5 d for PLT. Donor chimerism reached ≥ 95% in all pts by day 100 with a median follow up of 703d (128–2025). Toxicities were grade (3) hematuria (n=1), (3–4) infection (n=7), (4) pulmonary fibrosis (n=1), (4) hearing loss (n=1), (4) neurotoxicity (n=1). GVHD: grade II-III aGVHD (3/8), cGVHD (3/8). Six patients are alive and NED post allo SCT. There has been one NRM (cGVHD) and one relapse mortality. The OS at one year is 66.7%. Conclusions: MA AutoSCT followed by RI AlloSCT is feasible and well tolerated in pediatric pts with R/R HD. A larger study with longer follow up is required to determine if this approach will reduce relapse, long term toxicity and/or improve survival. No significant financial relationships to disclose.

Updated results of BICC-C study comparing first-line irinotecan/fluoropymidine combinations with or without celecoxib in mCRC: Updated efficacy data

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4027-4027 ◽  
Author(s):  
C. Fuchs ◽  
J. Marshall ◽  
E. Mitchell ◽  
R. Wierzbicki ◽  
V. Ganju ◽  
...  
Keyword(s):  
Survival Rate ◽  
Randomized Study ◽  
Progression Free Survival ◽  
First Line ◽  
Double Blind ◽  
Period 2 ◽  
Common Grade ◽  
Grade 3 ◽  
One Year

4027 Background: This multicenter, randomized study assessed efficacy & safety for irinotecan/fluoropyrimidines combinations in previously untreated mCRC. Methods: Pts were randomized to: infusional FOLFIRI, modified bolus IFL (mIFL), or CapeIri; and concurrent celecoxib or placebo in a double-blind fashion. The protocol was amended in April 2004: bevacizumab (bev) was added to the FOLFIRI and mIFL arms, whereas CapeIri was discontinued. Period 1 (P1) and Period 2 (P2) designate subjects enrolled before or after the amendment. Initial efficacy & safety analyses were reported at ASCO ’06. We now report follow-up of 46 months for P1 and 31 months for P2. Results: 430 pts were treated in P1 and 117 pts in P2. Baseline characteristics and post-study treatment were balanced. P1 results: Median progression free survival (PFS) was 7.6 mos for FOLFIRI; 5.9 mos for mIFL (p=0.004); and 5.8 mos for CapeIri (p=0.015). Median overall survival (OS) was 23.1 mos for FOLFIRI; 17.6 mos for mIFL (p=0.087); and 18.9 mos for CapeIri (p=0.27). One-year survival rate favored FOLFIRI (75%) compared to either mIFL (65%) or CapeIri (66%). Overall Response Rate (ORR) was 47% in FOLFIRI, 43% in mIFL, 39% in CapeIri (not significantly different). P2 results: Median PFS was 11.2 mos for FOLFIRI+bev and 8.3 mos for mIFL+bev (p=0.28). Median OS was not reached for FOLFIRI+bev but was 19.2 mos for mIFL+bev (p=0.007). One-year survival rate favored FOLFIRI+bev (87%) when compared to mIFL+bev (61%). ORR was 58% for FOLFIRI+bev and 54% for mIFL+bev (p=0.73). Common grade = 3 AEs are listed below. Celecoxib did not impact safety or efficacy. Conclusions: First line FOLFIRI or FOLFIRI+bev were superior to their comparators and show favorable results in survival and tolerability in untreated mCRC. Median survival for FOLFIRI+bev has not been reached. [Table: see text] No significant financial relationships to disclose.

Phase Ib/IIa study of sustained release lipid inhalation targeting cisplatin by inhalation in the treatment of patients with relapsed/progressive osteosarcoma metastatic to the lung

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9525-9525 ◽  
Author(s):  
A. J. Chou ◽  
M. D. Bell ◽  
C. Mackinson ◽  
R. Gupta ◽  
P. A. Meyers ◽  
...  
Keyword(s):  
Adverse Events ◽  
Sustained Release ◽  
Pulmonary Disease ◽  
Study Drug ◽  
World Health ◽  
Phase Ib ◽  
Initiation Of Therapy ◽  
Grade 3 ◽  
One Year ◽  
Disease Free

9525 Background: Pulmonary relapse is the most common site of relapse for patients with osteosarcoma (OS). Few therapeutic options are available for these patients. By encapsulating the drug within liposomes, sustained release lipid inhalation targeting (SLIT) cisplatin is a novel sustained-release formulation of cisplatin designed for administration via inhalation, thereby targeting the lungs with little systemic exposure. Methods: A two-center, open-label, phase Ib/IIa study was designed to characterize the safety and efficacy of SLIT cisplatin in patients with OS metastatic to the lung. Two dose levels were utilized: 24 mg/m2/dose, and 36 mg/m2/dose. Study drug was administered via nebulizer once every two weeks. OS patients with only pulmonary relapse were eligible. Toxicities were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. Response was evaluated radiographically according to the World Health Organization criteria after every 2 cycles. When clinically indicated, metastasectomy was undertaken in patients on study after 2 cycles, and levels of SLIT cisplatin were measured in tumor samples upon metastasectomy. Results: Fourteen patients have been treated on study. SLIT cisplatin has been well tolerated in heavily pre-treated patients who have received multiple cycles of therapy, including one patient, approaching cumulative doses of 840 mg of SLIT cisplatin over one year and a second patient receiving 1,020 mg. Specifically, no patients have experienced hematologic toxicity, nephrotoxicity or peripheral neuropathy. Nausea (= grade 3) was attributed to study drug in 5 patients. Respiratory symptoms (= grade 3) were attributable to study drug in 4 patients. No adverse events required discontinuation of study drug. Two patients are pulmonary disease free one year after initiation of therapy. Conclusions: SLIT cisplatin is well tolerated in patients with pulmonary relapse of OS. Two of 14 patients are pulmonary disease free one year after initiation of therapy. SLIT cisplatin provides a novel therapeutic modality for patients with pulmonary relapse of OS, and warrants further study. No significant financial relationships to disclose.

scholarly journals Combined Treatment of Bortezomib, Continuous Low-Dose Cyclophosphamide and Dexamethasone Followed By One Year of Maintenance Treatment for Refractory or Relapsed Multiple Myeloma Patients: A Prospective Phase II Study

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4733-4733
Author(s):  
Esther GM Waal de ◽  
Linda Munck de ◽  
Gerhard Woolthuis ◽  
Annet velden Van Der ◽  
Yvonne Tromp ◽  
...  
Keyword(s):  
Overall Survival ◽  
Maintenance Therapy ◽  
Research Funding ◽  
Low Dose ◽  
Progression Free Survival ◽  
Free Survival ◽  
First Relapse ◽  
Grade 3 ◽  
One Year

Abstract Introduction: Combination therapy for longer periods but at low dose, also called metronomic scheduling, might be an effective manner to treat patients with relapsing myeloma. In particular if the used agents attack the malignant clone in an alternative manner. Therefore we used the combination of bortezomib, dexametasone and daily low dose of oral cyclophosphamide as an induction regimen followed by one year of maintenance therapy consisting of bortezomib and cyclophosphamide. Methods: Relapsing myeloma patients, bortezomib naïve, were treated with three cycles of 1.3 mg/m2 bortezomib at day 1, 4, 8 and 11, cyclophosphamide 50 mg daily, and 20 mg dexamethasone at day 1, 2, 4, 5, 8, 9, 11 and 12 followed by three cycles of bortezomib 1.6 mg/m2 (day 1, 8, 15 and 2), cyclophosphamide (50 mg) daily and dexamethasone (20 mg) at day 1, 2, 8, 9, 15, 16, 22 and 23. Maintenance therapy consisting of bortezomib 1.3 mg/m2 every two weeks and daily dose of 50 mg cyclophosphamide for one year was applied to patients in partial or complete remission. Primary endpoints were toxicity during re-induction and maintenance therapy. Secondary endpoints were response to treatment and progression free and overall survival. Results: 59 patients with relapsing multiple myeloma were included of whom 69% were in first relapse (Table 1). The upfront treatment consisted mainly of thalidomide-based and vincristine-based chemotherapy and 40% of the patients have been treated with an autologous stem cell transplantation. All 6 cycles of induction chemotherapy could be given in 49% of the patients. Premature discontinuation before starting maintenance therapy was due to toxicity (31%), progressive disease (7%), death (7%) or other reasons (6%). Myelosuppression was the most common side effect with WHO grade 3-4 in 31% of the patients. Neuropathy grade 3-4 was observed in 16% of patients, partially due to the fact that bortezomib was given intravenously during the first 2 yrs of the protocol which included 76% of the patients. Maintenance therapy was started in 47% of the patients with a median duration of 7.3 months (range 0.36.-13.4). Grade 3-4 toxicity was observed in 25% of the patients including infections (n=3) and myelosuppression (n=3) which did not resulted in discontinuation of therapy. Median follow up time was 29 months with an overall response of 62%, and a very good partial response (VGPR), complete remission (CR) in 21% and 7% of the patients respectively. During the maintenance phase an improvement in responsiveness was observed in 25% of the patients. The CR rate increased with 9% to a total of 16%. VGPR rate was 20% and 16% of the patient had a PR. At end of the maintenance therapy 50% of patients started with maintenance had stable disease. The median progression free survival (PFS) was 17.2 months (range 0.13 – 43.5) as depicted in figure 1. and the median overall survival was 21.6 months (range 0.46-54.4, figure 2). During follow up 33 % of the patients died due to progression of MM. Conclusion: The present study demonstrates that combination therapy with bortezomib, continuous low dose cyclophosphamide and dexamethasone is an effective and manageable regimen. Adding a year of maintenance was feasible with limited side effects and an increase in CR rate. Table 1: patient characteristics Patients (%) Age, mean (min,max) 69 (46-86) Sex Male 56 Female 44 Relapse number First relapse 75 Second relapse 20 Third relapse 5 Performance status 0 65 1 29 2 5 M-protein heavy chain IgA 18 IgG 65 Light chain disease 18 Polyneuropathy No 61 Yes 39 Figure 1: Progression free survival Figure 1:. Progression free survival Figure 2: Overall survival Figure 2:. Overall survival Disclosures Waal de: Jansen Cilag: Research Funding. Munck de:Jansen Cilag: Research Funding. Woolthuis:Jansen Cilag: Research Funding. velden Van Der:Jansen Cilag: Research Funding. Tromp:Jansen Cilag: Research Funding. Hoogendoorn:Jansen Cilag: Research Funding. Vellenga:Jansen Cilag: Research Funding. Hovenga:Jansen Cilag: Research Funding.

Phase II trial with carboplatin/gemcitabine induction chemotherapy followed by radiotherapy concomitantly with paclitaxel/gemcitabine in stage III non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7139-7139 ◽  
Author(s):  
V. Hirsh ◽  
M. Duclos ◽  
L. Souhami ◽  
P. Del Vecchio ◽  
L. Ofiara ◽  
...  
Keyword(s):  
Progressive Disease ◽  
Liver Enzymes ◽  
Phase Ii Trial ◽  
Stage Iii ◽  
Stage Iii Nsclc ◽  
Grade 3 ◽  
One Year ◽  
Ecog Ps

7139 Background: The optimal combination of concomitant thoracic radiotherapy (TRT) and CT in stage III unresectable NSCLC remains unclear. The role of induction CT with Cb/G regimen, less toxic than Cisplatin/G, has not been established in stage III NSCLC. Methods: Forty-two patients (pts), 41 evaluable, entered this trial between January 2003 and November 2004, 27 males, 14 females, median age 60 (37–70), 19 pts with ECOG PS 0, 22 pts with PS 1, 22 pts with stage III A (N2), and 19 pts with stage III B (N2, N3). They received Cb AUC 5 i.v. on day 1 and G 1000 mg/m2 i.v. on days 1 + 8 every three weeks x 2 cycles, followed on day 50 by TRT, 60 Gy over 6 weeks, concomitantly with P 50 mg/m2 i.v. and G 100 mg/m2 i.v. on days 1 + 8 every three weeks x 2 cycles. Results: After induction CT, partial response (PR) was 73.1% (30 pts), stable disease (SD) 24.4% (10 pts), and 2.5% (1 pt) had progressive disease. After TRT and P/G, 19.5% (8 pts) had CR, 75.6% (31 pts) PR, and 4.9% (2 pts) PD. Median time-to-disease progression was 11.5 months. Median survival has not been reached yet, but surpassed 16.5 months; one-year survival is 71% (29 pts). Twenty three patients are still alive, after minimal follow-up of 13 months. First site of PD was in lungs in 7 pts, in brain 5 pts, in bones 4 pts; 2 pts died without PD, of cardiovascular disease. Toxicity of induction CT was minimal. During TRT and CT, grade 3 neutropenia, thrombocytopenia, and anemia occurred in 8 pts, 3 pts, and 3 pts respectively, grade 4 neutropenia and thrombocytopenia in one pt each. Nine pts received red cell transfusions, one pt platelet transfusion. One patient developed esophageal fistula with grade 4 toxicity, 3 pts had grade 3 esophagitis, 2 pts grade 3 infections, and one pt grade 3 dermatitis and elevation of liver enzymes. Conclusions: This regimen is effective, well tolerated, and appears to be an excellent choice for stage III NSCLC. Sponsored by Eli Lilly Canada. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document