Survival Improvement in the Last 45 Years in Patients with Multiple Myeloma: Real-World Data from a Single Center

Abstract INTRODUCTION: Multiple myeloma (MM) is the second most common blood cancer, with estimated 5-year overall survival (OS) rate of 50%. Survival rates have steadily increased over last decades due to the introduction of high-dose melphalan with autologous stem cell transplantation (ASCT) and newer drugs (thalidomide, lenalidomide and bortezomib). Nevertheless, most studies in MM do not reflect the true real-world population. The aims of the present study were to analyze the survival outcomes, as well as to determine the incidence and causes of early mortality and time to next therapy (TTNT) over time, in patients diagnosed with MM, treated and followed at a single institution. METHODS: We reviewed the clinical records of patients with MM diagnosed at a single institution from January 1970 to December 2015. One thousand one hundred sixty-one patients (591 [50.9%] male; median age at diagnosis 64 years) was the final study population. Median follow-up for alive patients was 5.4 years (range, 0.5-34.4 years). The diagnosis of MM was based on international criteria established during the different periods analyzed. Baseline demographics, clinical and laboratory data, treatment and follow-up were collected. The population was divided into three periods, which included: group A (1970 to 1985), group B (1986 to 1999) and group C (2000 to 2015) (Table 1). The Ethics Committee of the Hospital Clínic of Barcelona approved the study. RESULTS: The median OS (mOS) of all patients was 3.6 years (95% CI: 3.2-3.8). We observed an improvement in mOS during follow-up (Group A: 1.7 years [95% CI: 1.23-2.06]; Group B: 2.92 years [95% CI: 2.44-3.32]; Group C: 5.01 years [95% CI: 4.31-5.52]; p<0.00001). The 5-year OS were 21%, 32% and 50%, respectively (Figure 1A). These findings were maintained in the stratified analysis according to 3 periods by age: < 65 years old (Group A: 1.9 years [95% CI: 1.19-2.54]; Group B: 3.6 years [95% CI: 3.14-4.92]; Group C: 7.5 years [95% CI: 5.64-9.79]; p<0.00001); 65-75 years old (Group A: 1.5 years [95% CI: 0.86-2.26]; Group B: 2.3 years [95% CI: 1.91-2.96]; Group C: 4.3 years [95% CI 3.8-5.25]; p<0.00001); and >75 years old (Group A: 1.1 years [95% CI: 0.12-2.13]; Group B: 1.8 years [95% CI: 1.30-2.74]; Group C: 2.8 years [95% CI: 1.99-3.24]; p<0.001) (Figure 1B to 1D). In the multivariate Cox proportional hazard model, these periods of time retained its independent prognostic value in terms of OS (Group B: HR=0.66; 95% CI 0.55-0.79; p<0.0001; Group C: HR=0.39; 95% CI 0.32-0.47; p<0.00001; compared with Group A). The early mortality rate (first 60 days after diagnosis) was 5.7%; 17.1% in the Group A, 5.7% in Group B, and 2.7% in Group C; p<0.001. The most frequent causes of early mortality were disease-related (46.7%, 63.6% and 66.6%; respectively), and infectious complications (36.7%, 22.7%, and 20.0%; respectively). In terms of time elapse between the start of front-line treatment until the beginning of the subsequent line, the median time to second line treatment in the group A, B and C, were 10.5 months (95% CI: 8.8-14.2), 18.6 months (95% CI: 15.9-21.8), and 26.6 months (95% CI: 23.5-30.7), respectively (p<0.00001) (Figure 1E). In the stratified analysis by age, these positive findings were only observed in the subgroup of patients diagnosed in the period from 2000 to 2015 (<65 years old: 24.6 months [95% CI: 22.1-28.8]; 65-75 years old: 19.1 months [95% CI: 15.6-23.7]; >75 years old: 15 months [95% CI: 9.4-18.5]; p<0.001) (Figure 1F). Regarding subsequent treatment lines (3rd and 4th), we did not observe statistically significant differences in TTNT neither by age nor by treatment periods. CONCLUSIONS: This study shows that the survival outcome have significantly improved over the last decades in all age groups, including the elderly, due to ASCT and novel drugs. The incidence of early mortality is low, being the most frequent MM progression and infectious complications. Finally, the time to second line treatment has increased, specifically during the period from 2000 to 2015, with no differences in subsequent lines. Disclosures Bladé: Janssen: Honoraria. Rosinol:Janssen, Celgene, Amgen, Takeda: Honoraria.

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Thalidomide Based Regimens (TBR) for Relapsed/Refractory Multiple Myeloma Patients: Long Term Follow Up, Unmaintained Remissions and Disease Control after Subsequent Treatments.

Blood ◽

10.1182/blood.v110.11.4812.4812 ◽

2007 ◽

Vol 110 (11) ◽

pp. 4812-4812

Author(s):

Maria Roussou ◽

Efstathios Kastritis ◽

Athanasios Anagnostopoulos ◽

Evangelos Eleftherakis-Papaiakovou ◽

Charis Matsouka ◽

...

Keyword(s):

Multiple Myeloma ◽

Progression Free Survival ◽

Free Survival ◽

Refractory Multiple Myeloma ◽

Long Term Follow Up ◽

Group A ◽

Pulse Dexamethasone ◽

Group B

Abstract Introduction: The effectiveness of thalidomide based regimens (TBR) in patients with relapsed/refractory multiple myeloma is well established. However, there are still limited data regarding the long term follow up after such regimens and the outcome of patients when they progress and they receive further treatment. In order to answer these questions we evaluated a series of 114 patients with relapsed/refractory multiple myeloma who were treated with TBR. None of these patients had previously received thalidomide, bortezomib or lenalidomide. Patients and Methods: All patients were treated with thalidomide and dexamethasone with or without other oral agents. More specifically 41 patients had received continuous thalidomide and pulse dexamethasone, 25 patients clarithromycin, continuous thalidomide and pulse dexamethasone, 43 patients intermittent thalidomide, pulse dexamethasone and cyclophosphamide and 5 patients continuous thalidomide, pulse dexamethasone and cyclophosphamide. Type of treatment at the time of progression after TBR, response to this treatment and progression free survival were recorded for each patient. Moreover, patients who received novel agents after progression to TBR, were divided into 2 subgroups, according to their resistance to thalidomide. In group A, patients had refractory or progressive myeloma while on TBR or within 2 months after discontinuation of TBR. In group B, myeloma progressed more than 2 months after discontinuation of TBR. Results: Among the 114 patients, 41 had not responded to TBR and 73 (64%) had achieved at least a partial response. The median PFS for all patients was 8 months. As of June 2007, 10 patients remain without progression from 28 to 81 months (median 54 months). Eight patients remain off treatment and without progression for a median of 56 months (range 28–81). Patients who did not respond to or progressed after TBR were analyzed for further treatment and outcome. Thirty eight patients (37%) died before receiving further treatment, 23 patients (23%) received conventional chemotherapy and 41 patients (40%) received continuous thalidomide and dexamethasone +/− clarithromycin or cyclophosphamide (17 patients), bortezomib and dexamethasone (7 patients), melphalan-bortezomib-dexamethasone and intermittent thalidomide (12 patients) or lenalidomide with dexamethasone (5 patients). Among these 41 patients, 24 were classified in group A (thalidomide resistant) and 17 in group B. Overall 17 (41%) achieved at least partial response after retreatment with novel agent-based regimens. A response was observed in 46% of patients in group A and in 35% of patients in group B. The median progression free survival of the 41 patients who received retreatment with novel agents was 9.2 months and the median survival was 17 months. Among the 23 patients who received conventional chemotherapy only five (21%) patients responded and the progression free survival and the median survival were 5.3 and 10.2 months, respectively. Conclusions: After an oral TBR regimen 6 (5%) patients remain without treatment and free of progression for more than 4 years. A significant number of patients who progressed after TBR and who received further treatment which included a novel agent achieved a response, including several patients who were resistant to TBR.

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Patterns of Disease Relapse and Progression in Patients with Multiple Myeloma After First Line Therapy with Autologous Stem Cell Transplantation: Implications for Patient Monitoring After Transplantation

Blood ◽

10.1182/blood.v118.21.825.825 ◽

2011 ◽

Vol 118 (21) ◽

pp. 825-825

Author(s):

Dmitriy Zamarin ◽

Manisha Bhutani ◽

Danielle Chimento ◽

Sergio Giralt ◽

Nikoletta Lendvai ◽

...

Keyword(s):

Multiple Myeloma ◽

Soft Tissue ◽

First Line ◽

Post Transplant ◽

First Line Therapy ◽

Line Therapy ◽

Group A ◽

One Year ◽

Group B

Abstract Abstract 825 BACKGROUND: Autologous stem cell transplantation (ASCT) is a widely used therapeutic option in first line treatment of multiple myeloma (MM). However, many patients eventually relapse. While precise knowledge of relapse and progression (R/PD) patterns would be important to generate evidence based surveillance recommendations after ASCT, such data is limited in the literature, especially in the era following the introduction of the free light chain assay. The purpose of this study is to examine the patterns of post-ASCT relapse and to derive evidence based recommendations for optimal surveillance of patients. METHODS: We performed a retrospective analysis on 258 patients with MM who underwent ASCT within one year of diagnosis at MSKCC between 2000 and 2010, as part of first line therapy. We used the IMWG standard criteria for serologic and clinical R/PD. We first determined for all patients the date of serologic R/PD. Patients identified as having serologic R/PD were further examined to determine whether clinical (anemia, renal failure, hypercalcemia, development of soft tissue lesions), radiologic (skeletal survey) or urinary R/PD had anteceded serologic R/PD. Several groups of patients were derived and further analyzed in terms of relapse patterns and adequacy of follow up. RESULTS: Among 258 patients, 173 were determined to have serologic R/PD at a median of 19.2 months post-transplant. Among these patients, on the dates of their serologic R/PD, 17 (9.8%) had concurrent overt symptomatic evidence of clinical/radiologic R/PD (Group A symptomatic R/PD), while 156 (90.2%) were found to have isolated asymptomatic serologic R/PD without apparent evidence of concomitant clinical/radiologic R/PD (Group B asymptomatic R/PD). Group A included patients with distinct and sometimes coinciding clinical characteristics (poor risk cytogenetics with aggressive disease (n=3), leptomeningeal relapse (n=1), soft tissue relapse (n=4) and acute severe anemia at relapse (n=3)); patients with IgA gammopathy (n=5); and patients considered to have inadequate serologic follow up intervals (range of follow up interval between date of serologic R/PD and prior serologic testing 149 to 245 days) (n=6). Upon further examination of group B, 44 patients had radiologic imaging at the time of serologic R/PD (within 4 weeks following the date of serologic R/PD). Fourteen among them (32%) had evidence of new bone lesions. Among all 173 patients with serologic R/PD, 83 patients had a skeletal survey within one year prior to the date of serologic R/PD. Only 3 (3.6%) had evidence of radiologic R/PD anteceding serologic R/PD. All 3 patients were considered to have had inadequate serologic follow up interval (Range 208 to 252 days). Abnormal urine immunofixation (UIF) anteceded serologic R/PD in 5 out of 41 (12%) patients tested who had achieved CR post transplant. In these patients the abnormal UIF anteceded the serologic R/PD by a mean of 2.4 months. Abnormal UPEP anteceded serologic R/PD by 1.9 months in only 1 out of 40 (2.5%) patients tested who had achieved less than CR post transplant. CONCLUSIONS: Based on the results of this analysis, several conclusions can be drawn: 1) The vast majority of R/PD in patients with MM are asymptomatic R/PD detected first by serologic studies. A small percentage of patients (those with aggressive cytogenetics, specific relapse types including soft tissue, severe cytopenia, and IgA gammopathy) will have symptomatic R/PD with overt concomitant evidence of clinical and/or radiologic R/PD at the time of serologic R/PD; 2) Among patients who have apparent asymptomatic R/PD, a significant percentage will have evidence of skeletal lesions and therefore imaging should be recommended in these patients; 3) In the absence of serological R/PD, routine surveillance screening with yearly skeletal surveys cannot be recommended based on this analysis since this test was not useful in any of the analyzable patients in whom it was obtained; 4) Aside from few patients in CR whose relapse may be detected earlier by UIF (with probably no clinical benefit), all patients with multiple myeloma whose disease progresses will have serologic R/PD at the time of progression and follow up limited to serologic testing may well be sufficient for monitoring patients with MM post transplant. Disclosures: No relevant conflicts of interest to declare.

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A population-based study evaluating metastatic renal cell cancer (mRCC) patients treated with interferon (IFN) alone, first-line IFN then second-line sunitinib, or sunitinib alone

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.15572 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 15572-15572 ◽

Cited By ~ 4

Author(s):

C. K. Kollmannsberger ◽

D. Y. Heng ◽

N. Murray ◽

K. N. Chi

Keyword(s):

Overall Survival ◽

Standard Treatment ◽

Population Based ◽

Phase Iii ◽

Second Line ◽

First Line ◽

Group A ◽

Group B ◽

The Impact

15572 Background: Previously, immunotherapy agents such as IFN were the only treatments available for mRCC. Sunitinib has demonstrated prolonged progression free survival in a phase III trial but overall survival benefit has yet to be determined and few patients (pts) with poor MSKCC prognostic profiles were included. Methods: The province-wide BC Cancer Agency Registry was cross-referenced to the central pharmacy database to identify all pts with the diagnosis of mRCC who were treated with IFN and/or sunitinib. Sunitinib became available after October 2005 under an expanded access program or as standard treatment. Three groups of pts were identified: Group A consisted of pts who received IFN alone between January 2003 to October 2005, Group B was all pts who progressed on first-line IFN after October 2005 and subsequently were treated with second-line sunitinib and Group C was all pts treated with first-line sunitinib. Baseline characteristics and overall survival were collected on all patients. Results: A total of 75 patients were identified with 36 patients in Group A, 23 patients in Group B, and 16 patients in Group C. Data are reported from the initiation of IFN in Group A and the initiation of sunitinib in Groups B and C. Median follow-up was 6.0 months in group A, 7.6 months in group B, and 6.2 months in group C. Median age of treatment initiation (62y vs. 60y vs. 62y), number of metastatic sites (>1 site in 63% vs. 61% vs. 56%), and Karnofsky performance status (79 vs. 86 vs. 81) were similar between groups A, B and C, respectively. The MSKCC prognostic profiles were favorable, intermediate and poor in 26%, 51% and 23% in group A, 17%, 65% and 17% in group B and 31%, 38% and 31% in group C, respectively. The estimated 6-month overall survival in groups A, B and C was 56%, 72% and 100%, respectively (log rank A vs C p=0.009; log rank B vs C p=0.042). Conclusion: With the limitations of retrospective analysis and preliminary follow-up, the introduction of sunitinib as standard treatment into the general population of patients with mRCC appears to be associated with a longer overall survival compared to patients treated with IFN alone. Population-based analysis on the impact of the introduction of sunitinib therapy is ongoing. No significant financial relationships to disclose.

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A randomized phase II factorial design trial of CPT-11 versus PTX versus each combination with S-1 in patients with advanced gastric cancer refractory to S-1: Final results of OGSG0701.

Journal of Clinical Oncology ◽

10.1200/jco.2015.33.3_suppl.117 ◽

2015 ◽

Vol 33 (3_suppl) ◽

pp. 117-117 ◽

Cited By ~ 4

Author(s):

Kazuhiro Nishikawa ◽

Hiroshi Imamura ◽

Tomono Kawase ◽

Masahiro Gotoh ◽

Yutaka Kimura ◽

...

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Advanced Gastric Cancer ◽

Progression Free Survival ◽

Correct Selection ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Group A ◽

Group B

117 Background: S1 + platinum (SP) is recognized as standard first-line chemotherapy for advanced gastric cancer(AGC), and S1 monotherapy is suggested for frail AGC patients or adjuvant setting in Japan. However, taxane or CPT-11 were often employed as second-line treatment for the patients who were resistant to S1-containing regimen. A retrospective analysis has reported that S1 combination chemotherapy extended overall survival as second-line treatment for AGC. Methods: Patients with AGC who confirmed disease progression by imaging after the first-line therapy with S1 or SP were randomized in four groups; CPT-11 150 mg/m2, day1, q2w (Group A), PTX 80 mg/m2, day1, 8,15, q4w (Group B), CPT-11 80 mg/m2, day1, 15, S-1 80 mg/m2, day1-21, q5w (Group C1), PTX 50 mg/m2,day1, 8, S1 80 mg/m2, day1-14, q3w (Group C2). Primary endpoint was overall survival (OS), and secondary endpoints were progression free survival (PFS), overall response rate (ORR) and safety. Sample size was set at 100 to 120 to achieve 2 months improvement of OS by using CPT-11 or by adding S1 with approximately 80% probability of the correct selection. Results: From July 2008 to March 2012, 127 patients were enrolled. The OS was 11.3/11.3/14.6/10.5 months(M) (Group A/B/C1/C2), 11.8M in Group A+C1 and 11.1M in Group B+C2 (p=0.922, HR: 0.981 [0.679-1.419]), 11.3M in Group A+B and 11.1M in Group C1+C2 (p=0.808, HR: 0.952 [0.643-1.412]), respectively. The PFS was 3.0/4.4/3.8/3.5M (Group A/B/C1/C2), 3.6M in Group A+C1 and 4.1M in Group B+C2 (p=0.035, HR:0.674 [0.468-0.972]) 3.7M in Group A+B and 3.7M in Group C1+C2 (p=0.931, HR: 1.017 [0.643-1.412]). The ORR was 7.1/16.3/4.5/5.0% (Group A/B/C1/C2), 4.7%[1.7-15.2] in Group A+C1 and 12.7%[5.6-23.5] in Group B+C2 (p=0.241), 11.8%[5.8-20.6] in Group A+B and 4.6%[0.6-16.2] in Group C1+C2 (p=0.572).Major Grade 3/4 toxicity (Group A/B/C1/C2, %), was leukopenia (12/7/5/0), neutropenia (29/16/24/24), nausea (7/2/10/5), diarrhea (5/0/10/0), and fatigue (5/2/10/5). Conclusions: From our results, we do not recommend consecutive use of S1 but CPT-11 or PTX monotherapy as second-line treatment in AGC refractory to S1 or SP. Clinical trial information: 000000677.

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The Outcome of Different Types of Second-Line Therapy in Multiple Myeloma Patients Relapsing After Uniform Front-Line Treatment with High-Dose Melphalan and Autologous Stem Cell Transplantation.

Blood ◽

10.1182/blood.v114.22.2892.2892 ◽

2009 ◽

Vol 114 (22) ◽

pp. 2892-2892

Author(s):

Claudia Crippa ◽

Samantha Ferrari ◽

Monica Drera ◽

Marinella Calarco ◽

Antonio Regazzoli ◽

...

Keyword(s):

Multiple Myeloma ◽

Stem Cell ◽

High Dose ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Second Line Therapy ◽

Line Therapy ◽

High Dose Melphalan

Abstract Abstract 2892 Poster Board II-868 Background and aim. While multiple myeloma (MM) still remains largely incurable, therapeutic options for patients with MM are expanding. However the best way to use the different effective regimens, either in combination or in sequence, during the course of MM in the single patient is still unknown. Data from controlled studies rarely report the treatments received before and after the enrollment of patients in the clinical trial, which may significantly impact on response and survival. As an example, the best treatment for patients relapsing after first-line high-dose melphalan (HD-Mel) and autologous stem cell transplantation (ASCT) is not standardized. To this end we have retrospectively analyzed an uniform cohort of such patients treated at our Institution, comparing their outcome according to the type of second-line and further consolidation treatment received. Patients and methods. In 156 patients affected by MM and treated between 1997 and 2008 with HD-Mel and ASCT as first line therapy, relapse has occurred in 92 (59%). Females were 39 (42%), males 53 (58%), median age was 60 (range 34-75). As induction therapy before ASCT, 89 (97%) had received VAD regimen, and only 3 (3%) thalidomide/bortezomib-based regimen. Sixty-one patients (66%) had received a single ASCT and 31 a double ASCT (34%). A second-line therapy was given to 87/92 patients. They were subdivided in 3 subgroups according to the type of second-line treatment received: 1) thalidomide-based regimens (THAL) were given to 55 pts (63%) followed by a consolidation ASCT in 13 (24%) 2) bortezomib-based regimens (BORT) were used in 13 (15%) and subsequent ASCT in 3 of them (23%) 3) chemotherapy and/or steroids (CHEMO) were used in 19 (22%) followed by ASCT in 15 (79%). Median follow-up from diagnosis was 57 (13-145) in THAL, 39 (17-140) in BORT and 59 months (25-113) in CHEMO respectively. The baseline characteristics, including age, of the three subgroups were similar as well as the CR/VGPR and ORR rates obtained after first-line treatment (THAL 47% and 87%; BORT 69% and 100%; CHEMO 53% and 100%, respectively). The subgroups also did not differ in median duration of first response, which ranged from 13 to 15 months and median time to second treatment, which was 26 months in all subgroups. The proportion of patients receiving a double ASCT were significantly higher in BORT (69%) compared to THAL (34%) (P=0.03) and CHEMO (5%) (p=0.002), and in THAL (34%) compared to CHEMO (5%) (p=0.015). Results. After second line therapy the ORR (CR+VGPR+ PR) of the three subgroups was: THAL 60%, BORT 77% and CHEMO 58%. (p=NS). The second CR/VGPR rate was non significantly higher after BORT (46%) than after THAL (25%) or CHEMO (21%) (p=0.17). Moreover, when considering patients not undergoing second-line consolidation ASCT, the ORR was significantly better in THAL and BORT subgroups compared to CHEMO (50%, 70% and 0%, respectively p=0.03). After a median follow-up from second-line treatment of 28 months (range 1-99), the 2-y PFS was 38% after THAL (median 18 months), 34% after BORT (median 16 months) and 17% after CHEMO (median 12 months) (p=NS). The 2-y OS was 78% (median 49 months), 70% (median not reached), and 70% (median 33 month) after THAL, BORT and CHEMO, respectively (p=NS). However when considering patients not undergoing second-line consolidation ASCT, the 2-y OS was significantly better after THAL and BORT than after CHEMO (p=0.024). Conclusion. In spite of having frequently received a first-line double ASCT, BORT patients seemed to achieve responses of better quality. However, in patients relapsing after first-line HD-Mel and ASCT, the choice of THAL, BORT or CHEMO-based regimens as second-line therapy did not seem to impact on overall response rates and survival, provided that patients treated with CHEMO could be consolidated with a second ASCT. Hence newer drugs may be reserved for those patients not fit for ASCT, preserving them for effective third-line treatment in the other patients. Disclosures: No relevant conflicts of interest to declare.

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Sequential therapy with sorafenib and sunitinib in renal cell carcinoma

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.5106 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 5106-5106 ◽

Cited By ~ 15

Author(s):

A. Dham ◽

A. Z. Dudek

Keyword(s):

Renal Cell Carcinoma ◽

Disease Progression ◽

Median Duration ◽

Stable Disease ◽

Response To Treatment ◽

Second Line ◽

Line Therapy ◽

Group A ◽

Group B

5106 Background: Sunitinib and sorafenib are two small-molecule tyrosine kinase inhibitors (TKI) that have been shown to have antitumor activity in advanced renal cell carcinoma (RCC). However, the optimal sequence of first- and second-line therapies with sunitinib and sorafenib is still unclear. The purpose of this study was to assess whether an objective disease response could be identified in patients after receiving sequential treatment with these two agents. Methods: Patients who had progressed or experienced unacceptable toxicity after first-line therapy with either sunitinib or sorafenib and then subsequently received second-line therapy with the other TKI agent were evaluated for their response to sequential treatment using RECIST criteria. Results: Thirty-seven patients were identified (29 male and 8 female) with a median age of 62 years (range 32–75). Twenty-three patients received sorafenib followed by sunitinib (Group A), and 14 patients received sunitinib followed by sorafenib (Group B). According to Memorial Sloan-Kettering prognostic model, 35% of patients in Group A had favorable risk, 52% had intermediate and 13% had poor risk, whereas 50% of patients in Group B had favorable risk, 43% had intermediate and 7% had poor risk. Three patients (13%) in Group A and two (14%) in Group B switched TKI due to toxicity, while all remaining patients switched due to disease progression. For patients in Group A, median duration of stable disease after starting sunitinib was 32 weeks (range 6–37 weeks)(median follow up 266 days); 9% were not evaluable for response to treatment; 34% had disease progression; and four patients (17%) had an objective partial response of 31%, 36%, 27% and 50%, respectively. For patients in Group B, median duration of stable disease after starting sorafenib was 8 weeks (range 4–10 weeks) (median follow up 179 days); 7% were not evaluable for response to treatment; 50% had disease progression; and one patient (7%) had no evidence of disease after tumor resection. The median duration of disease control in Groups A and B was 42 weeks (range: 10–113 wks) and 30.5 weeks (range: 4–56 wks), respectively. Conclusions: While disease control was observed in both sequences, the duration of response was longer in patients receiving sorafenib followed by sunitinib. [Table: see text]

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A randomized phase III trial of second-line chemotherapy comparing CPT-11 alone versus S-1 plus CPT-11 combination therapy in advanced gastric cancer refractory to first-line therapy with S-1 (JACCRO GC-05).

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.3_suppl.87 ◽

2014 ◽

Vol 32 (3_suppl) ◽

pp. 87-87 ◽

Cited By ~ 2

Author(s):

Kazuhiro Nishikawa ◽

Kazuaki Tanabe ◽

Masashi Fujii ◽

Chikara Kunisaki ◽

Akihito Tsuji ◽

...

Keyword(s):

Response Rate ◽

Progression Free Survival ◽

Line Treatment ◽

Second Line ◽

First Line ◽

First Line Therapy ◽

Line Therapy ◽

Group A ◽

Group B ◽

Line Chemotherapy

87 Background: In East Asia, S-1 + CDDP (SP) has been employed as first-line therapy for advanced gastric cancer (AGC) from the results of SPIRITS trial. Patients who were resistant to chemotherapy with S-1 in the first-line treatment were widely treated with taxane alone or CPT-11 alone as the second-line treatment. On the other hand, the response rate of combination therapy with S-1 is higher than that of CPT-11 alone. Then, we hypothesized that S-1 + CPT-11 prolongs survival in the second-line treatment comparing with CPT-11 alone after failure in the first-line treatment with S-1. (NCT00639327). Methods: Patients with AGC who confirmed disease progression by imaging after the first-line therapy with SP, S-1 + cocetaxel or S-1 alone except S-1 + CPT-11 were allocated into S-1 plus CPT-11 group (Group A) or CPT-11 alone group (Group B) as second-line chemotherapy. Patients who were relapsed to adjuvant chemotherapy with S-1 were not enrolled. Primary endpoint was overall survival, and secondary endpoints were progression free survival, response rate and adverse events. Results: From March 2008 to June 2011, 304 patients were enrolled, and 294 were eligible for analysis. The overall survival was 8.8 months (M) in the Group A and 9.4M in the Group B. There is no statistically significant difference in both groups (P=0.9156). The progression free survival was 4.8M in the Group A and 4.9M in the Group B (P=0.1568). The response rate was 7.6% in the Group A and 7.4% in the Group B. Grade 3 or higher leukopenia, neutropenia and febrile neutropenia were observed more frequently in the Group A than in the Group B. Conclusions: From our results, we do not recommend consecutive use of S-1 as second-line treatment in patients who are refractory to S-1 in first-line chemotherapy. Clinical trial information: 00639327.

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INTRAUTERINE CONTRACEPTIVE DEVICE

The Professional Medical Journal ◽

10.29309/tpmj/18.4997 ◽

2018 ◽

Vol 25 (10) ◽

pp. 1518-1524

Author(s):

Faryal Sardar ◽

Ifat Balouch ◽

Naseem Bajari

Keyword(s):

Tertiary Care ◽

Contraceptive Device ◽

Care Hospital ◽

Intrauterine Contraceptive ◽

Group A ◽

Group B ◽

Stratified Analysis ◽

Effect Of Age ◽

Trial Setting

Objectives: To compare the frequency of effectiveness of postpartum IUCD(PPIUCD) with interval IUCD at Tertiary care Hospital in Hyderabad. Study Design: Randomizedcontrolled trial. Setting: Gynaecological and Obstetrical Department, Liaquat UniversityHospital, Hyderabad. Period: Six months from February 2016 to July 2016. Material andMethods: Total 100 women were studied. All the women with age 18 to 40 years, having atleast one alive child were included in the study. Women were divided in two groups according tocontraception methods of IUCD (50 women in each group). In Group-A IUCD were inserted afterplacental delivery within 10 minutes to 48 hours (PPIUCD) and in group-B IUCD were insertedany time of women’s menstrual cycle (Interval IUCD). All the women were followed for 6 months.All the data regarding effectiveness among both groups was recorded. Results: Mean ± SDage of group-A (PPIUCD) patients was 26.02 ± 5.87 years while group-B (Interval IUCD) was26.34 ± 5.95 years. Majority of patient’s i-e; 76.0% of group-A and 68.0% of group-B were fromurban areas. IUCD was successfully place among 94.0% women of group-A and among 98.0%women in group-B. At the end of 6 months follow-up, 86.0% patients of group-A continuedPPIUCD while in group-B, 96.0% women continued Interval IUCD. After 6 months follow-up,effectiveness of IUCD was 90.0% in group-B and 80.0% in group-A. Stratified analysis revealedthat there was a non-significant effect of age on effectiveness of IUCD among both groups (Pvalues= 0.094 & 0.223 respectively) so was the parity (P values= 0.384 & 0.747 respectively).Conclusion: It was concluded that interval IUCD found to be effective method as compare topost postpartum IUCD (PPIUCD). While women have recently given birth to neonate were moreagreed to practice of PPIUCD, due to its quick insertion.

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Absorbable suture material in carotid surgery

VASA ◽

10.1024/0301-1526/a000468 ◽

2015 ◽

Vol 44 (6) ◽

pp. 451-457 ◽

Cited By ~ 4

Author(s):

Vincenzo Gasbarro ◽

Luca Traina ◽

Francesco Mascoli ◽

Vincenzo Coscia ◽

Gianluca Buffone ◽

...

Keyword(s):

Suture Material ◽

Absorbable Suture ◽

Paediatric Surgery ◽

Carotid Surgery ◽

Suture Materials ◽

Absorbable Suture Material ◽

Absorbable Sutures ◽

Group A ◽

Group B

Abstract. Background: Absorbable sutures are not generally accepted by most vascular surgeons for the fear of breakage of the suture line and the risk of aneurysmal formation, except in cases of paediatric surgery or in case of infections. Aim of this study is to provide evidence of safety and efficacy of the use of absorbable suture materials in carotid surgery. Patients and methods: In an 11 year period, 1126 patients (659 male [58.5 %], 467 female [41.5 %], median age 72) underwent carotid endarterectomy for carotid stenosis by either conventional with primary closure (cCEA) or eversion (eCEA) techniques. Patients were randomised into two groups according to the type of suture material used. In Group A, absorbable suture material (polyglycolic acid) was used and in Group B non-absorbable suture material (polypropylene) was used. Primary end-point was to compare severe restenosis and aneurysmal formation rates between the two groups of patients. For statistical analysis only cases with a minimum period of follow-up of 12 months were considered. Results: A total of 868 surgical procedures were considered for data analysis. Median follow-up was 6 years (range 1-10 years). The rate of postoperative complications was better for group A for both cCEA and eCEA procedures: 3.5 % and 2.0 % for group A, respectively, and 11.8 % and 12.9 % for group B, respectively. Conclusions: In carotid surgery, the use of absorbable suture material seems to be safe and effective and with a general lower complications rate compared to the use of non-absorbable materials.

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Laparoscopic Incisional and Ventral Hernia Repair with Absorbable Tacks in a Long Term Follow-up: A Retrospective Control Study

Reviews on Recent Clinical Trials ◽

10.2174/1574887114666190201111332 ◽

2019 ◽

Vol 14 (2) ◽

pp. 141-146

Author(s):

Simone Zanella ◽

Enrico Lauro ◽

Francesco Franceschi ◽

Francesco Buccelletti ◽

Annalisa Potenza ◽

...

Keyword(s):

Hernia Repair ◽

Ventral Hernia ◽

Ventral Hernia Repair ◽

The Elderly ◽

Long Term Follow Up ◽

Group A ◽

Group B ◽

Absorbable Tacks

Background: Laparoscopic Incisional and Ventral Hernia Repair (LIVHR) is a safe and worldwide accepted procedure performed using absorbable tacks. The aim of the study was to evaluate recurrence rate in a long term follow-up and whether the results of laparoscopic IVH repair in the elderly (≥65 years old) are different with respect to results obtained in younger patients. Methods: One hundred and twenty-nine consecutive patients (74 women and 55 men, median age 67 years, range = 30-87 years) with ventral (N = 42, 32.5%) or post incisional (N = 87, 67.5%) hernia were enrolled in the study. Patients were divided into two groups according to their age: group A (N = 55, 42.6%) aged <65 years and group B (N = 74, 57.4%) aged ≥65 years. Results: The mean operative time was not significantly different between groups (66.7 ± 37 vs. 74 ± 48.4 min, p = 0.4). To the end of 2016, seven recurrences had occurred (group A = 3, group B = 4, p = 1). Complications occurred in 8 (16%) patients in group A and 21 (28.3%) patients in group B. Conclusion: In conclusion, our results confirm that the use of absorbable tacks does not increase recurrence frequency and laparoscopic incisional and ventral repair is a safety procedure also in elderly patients.

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