scholarly journals Rituximab Maintenance Treatment of Relapsed/Resistant Follicular Non-Hodgkin's Lymphoma: Long-Term Outcome of the EORTC 20981 Phase III Randomized Intergroup Study

2010 ◽  
Vol 28 (17) ◽  
pp. 2853-2858 ◽  
Author(s):  
Marinus H.J. van Oers ◽  
Martine Van Glabbeke ◽  
Livia Giurgea ◽  
Richard Klasa ◽  
Robert E. Marcus ◽  
...  
Keyword(s):  
Maintenance Treatment ◽  
Statistical Significance ◽  
Maintenance Phase ◽  
Phase Iii ◽  
Remission Induction ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Rituximab Maintenance

Purpose In 2006, we published the results of the European Organisation for Research and Treatment of Cancer phase III trial EORTC 20981 on the role of rituximab in remission induction and maintenance treatment of relapsed/resistant follicular lymphoma (FL). At that time, the median follow-up for the maintenance phase was 33 months. Now, we report the long-term outcome of maintenance treatment, with a median follow-up of 6 years. Patients and Methods Overall, 465 patients were randomly assigned to induction with either six cycles of cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or rituximab plus CHOP (R-CHOP). Those in complete remission or partial remission after induction (n = 334) were randomly assigned to maintenance treatment with rituximab (375 mg/m2 intravenously once every 3 months) or observation. Results Rituximab maintenance significantly improved progression-free survival (PFS) compared with observation (median, 3.7 years v 1.3 years; P < .001; hazard ratio [HR], 0.55), both after CHOP induction (P < .001; HR, 0.37) and R-CHOP (P = .003; HR, 0.69). The 5-year overall survival (OS) was 74% in the rituximab maintenance arm, and it was 64% in the observation arm (P = .07). After progression, a rituximab-containing salvage therapy was given to 59% of patients treated with CHOP followed by observation, compared with 26% after R-CHOP followed by rituximab maintenance. Rituximab maintenance was associated with a significant increase in grades 3 to 4 infections: 9.7% v 2.4% (P = .01). Conclusion With long-term follow-up, we confirm the superior PFS with rituximab maintenance in relapsed/resistant FL. The improvement of OS did not reach statistical significance, possibly because of the unbalanced use of rituximab in post-protocol salvage treatment.

Rituximab Maintenance Treatment of Relapsed/Resistant Follicular Non- Hodgkin’s Lymphoma: Long-Term Outcome of the EORTC 20981 Phase III Randomized Intergroup Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 836-836 ◽  
Author(s):  
Marinus H.J. Van Oers ◽  
Martine Van Glabbeke ◽  
Liliana Baila ◽  
Livia Giurgia ◽  
Richard Klasa ◽  
...  
Keyword(s):  
Maintenance Treatment ◽  
Statistical Significance ◽  
Recurrent Infection ◽  
Maintenance Phase ◽  
Phase Iii ◽  
Remission Induction ◽  
Term Outcome ◽  
Long Term Outcome

Abstract Background. In 2005 we analyzed the results of a prospective randomized phase III intergroup trial evaluating the role of rituximab (R) both in remission induction and maintenance treatment of 465 relapsed/resistant follicular lymphoma (FL) patients. Major conclusions were that addition of R to CHOP induction yielded an increased ORR and CR rate, and that R maintenance strongly improved median progression free survival (PFS), both after induction with CHOP and R-CHOP, and overall survival (OS (van Oers et al Blood2006;108:3295). At that time the median follow for the maintenance phase was 33 months. Now we report the long-term outcome of maintenance treatment, with a median follow up of 6 years from start of maintenance. Study design. Patients with stages III or IV FL at initial diagnosis and relapsed after or resistant to a maximum of two non-anthracycline containing systemic chemotherapy regimens, were randomized to remission induction with either 6 cycles of standard CHOP (once every 3 weeks) or CHOP + R (375 mg/m2 at day 1 of each cycle of CHOP). Those with a complete or partial remission after 6 cycles of therapy underwent a second randomization to no further treatment (observation) or maintenance treatment with R (375 mg/m2 once every 3 months) until relapse or for a maximum period of two years. Results. 465 patients were randomized to induction with either CHOP (231) or R-CHOP (234). As reported, CHOP and R-CHOP induction yielded similar partial response rates (57% vs.56%), but significantly different CR rates (16% and 29%; p=0.0001). 334 patients were randomized to either R maintenance treatment (167) or observation (167). R maintenance resulted in a highly significant improvement of PFS: median 3.7 years versus 1.3 years in the observation arm (p<0.0001; hazard ratio 0.55). The advantage of R maintenance was observed both after CHOP induction (p< 0001: HR 0.37) and R-CHOP induction (p= 0.003; HR 0.69). The 5 years OS was 74% in the R maintenance arm and 64 % in the observation arm (p=0.07). That the highly improved PFS after R maintenance did not translate into a significant OS advantage might partially be explained by the fact that 41% of progressing patients received R as salvage therapy. This varied according to treatment arm: from 59% after CHOP followed by observation to 26% after R-CHOP followed by R maintenance. R maintenance was associated with a significant increase in grade 3/4 infections: 9.7% vs.2.4% (p= 0.01). 7 of the 167 patients had to discontinue R maintenance because of toxicity, mostly recurrent infection. Conclusion. With long term follow-up we confirm the superior PFS with R maintenance. The improvement of OS did not reach statistical significance, possibly due to the abundant use of R in post-protocol salvage treatment.

scholarly journals Two-component surface replacement implants compared with perichondrium transplantation for restoration of Metacarpophalangeal and proximal Interphalangeal joints: a retrospective cohort study with a mean follow-up time of 6 respectively 26 years

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Daniel Muder ◽  
Nils P. Hailer ◽  
Torbjörn Vedung
Keyword(s):  
Primary Outcome ◽  
Statistical Significance ◽  
Surface Replacement ◽  
Level Of Evidence ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Two Component ◽  
Pip Joint

Abstract Background The aim of our study was to compare the long-term outcome after perichondrium transplantation and two-component surface replacement (SR) implants to the metacarpophalangeal (MCP) and the proximal interphalangeal (PIP) joints. Methods We evaluated 163 joints in 124 patients, divided into 138 SR implants in 102 patients and 25 perichondrium transplantations in 22 patients. Our primary outcome was any revision surgery of the index joint. Results The median follow-up time was 6 years (0–21) for the SR implants and 26 years (1–37) for the perichondrium transplants. Median age at index surgery was 64 years (24–82) for SR implants and 45 years (18–61) for perichondium transplants. MCP joint survival was slightly better in the perichondrium group (86.7%; 95% confidence interval [CI]: 69.4–100.0) than in the SR implant group (75%; CI 53.8–96.1), but not statistically significantly so (p = 0.4). PIP joint survival was also slightly better in the perichondrium group (80%; CI 55–100) than in the SR implant group (74.7%; CI 66.6–82.7), but below the threshold of statistical significance (p = 0.8). Conclusion In conclusion, resurfacing of finger joints using transplanted perichondrium is a technique worth considering since the method has low revision rates in the medium term and compares favorable to SR implants. Level of evidence III (Therapeutic).

Meta-analysis of gender effect for first-line chronomodulated 5-fluorouracil-leucovorin-oxaliplatin (ChronoFLO) compared with FOLFOX or constant infusion (conventional delivery, CONV) against metastatic colorectal cancer (MCC) in three international controlled phase III randomized trials (RT)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4112-4112 ◽  
Author(s):  
F. Levi ◽  
P. Innominato ◽  
A. Poncet ◽  
T. Moreau ◽  
S. Iacobelli ◽  
...  
Keyword(s):  
Liver Metastases ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Constant Infusion ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Significant Difference

4112 Background: Gender predicted for the most effective schedule in a RT of ChronoFLO vs CONV against MCC: overall survival (OS) was significantly increased in men on chronoFLO vs FOLFOX, whereas the reverse was found in women (Giacchetti, JCO 2006). Methods: To assess the relevance of gender for patient (pt) outcome, meta-analysis was performed on individual pt data (IPD) from 3 RT in 845 MCC pts treated with chronoFLO vs CONV (346 F, 499 M at 36 centers in 1990–2002)(Lévi, JNCI 1994; Lancet 1997). Data bases were merged and updated at 9 y after inclusion of the 1st pt. Main prognostic factors were comparable in each RT according to gender and treatment arm (median age: 61y; PS=0, 46% pts; liver M, 85% pts; liver involvement >25%, 41% pts; lung M, 37% pts; CEA>10, 56% pts). Results: No significant difference was found according to delivery schedule or gender in the whole population for Response Rate (RR), Progression-Free Survival (PFS) and OS. However, men on chronoFLO had highest RR, longest PFS and OS. PFS and OS were highest in women on CONV ( Table ). The rate of complete macroscopic resections of liver metastases (R0+R1) was 12.5% in men on chronoFLO vs 7.8–8.5% in men on CONV or in women on either schedule. A complete histologic response of liver metastases was documented in 2.1% of the men on chronoFLO vs 0–1.1% in the other groups. The relative risk of an earlier death in men vs women was 0.76 [95% CL, 0.91 to 0.94] on chronoFLO and 1.24 [0.99 to 1.56] on CONV. Conclusions: This IPD meta-analysis of 3 RT in MCC with a minimum follow up of 5 years confirms that men benefit from chronoFLO as compared to CONV delivery, with regard to long term outcome and medico-surgical strategy. ChronoFLO should be preferred to conventional oxaliplatin-5-FU-LV schedules in men with MCC. Support: ARTBC Internationale, P. Brousse Hospital, Villejuif, France. [Table: see text] No significant financial relationships to disclose.

Long-term outcome of a phase III trial on neoadjuvant chemoradiation with capecitabine and irinotecan in patients with locally advanced rectal cancer: Updated results of the CinClare trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3603-3603
Author(s):  
Ji Zhu ◽  
Xinchen Sun ◽  
Anwen Liu ◽  
Yaqun Zhu ◽  
Tao Zhang ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Rectal Adenocarcinoma ◽  
Phase Iii ◽  
Control Group ◽  
Genotype 1 ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Ugt1a1 Genotype

3603 Background: Adding UGT1A1-guided irinotecan to capecitabine-based neoadjuvant chemoradiotherapy (CRT) significantly increased the pathological complete response (pCR) rate nearly doubling [J Clin Oncol. 2020 Dec 20;38(36):4231-4239]. Here, results of long-term outcome are reported. Methods: Eligible patients with clinical stage II/III rectal adenocarcinoma, UGT1A1 genotype *1*1 or *1*28 were randomized to the control group: pelvic radiation of 50 Gy/25 fractions with concurrent capecitabine, followed by a cycle of oxaliplatin and capecitabine; or the experimental group: radiation with capecitabine combined with weekly irinotecan 80 mg/m2 for patients with *1*1 or 65 mg/m2 for patients with *1*28, followed by a cycle of irinotecan and capecitabine. Surgery was scheduled for 8 weeks after completion of CRT. Five cycles of adjuvant XELOX chemotherapy were administered regardless of the pathologic result. Patients were stratified by UGT1A1 genotype (*1*1 vs. *1*28) clinical T stage (cT3 vs. cT4) and tumor distance from the anal verge (≤5 cm vs. > 5 cm). The primary end point of pCR was reached. Survival time was calculated from the date of randomization to the date of event or the last follow-up. Secondary endpoints were defined as local failure for local control (LC), tumor recurrence or death from any cause for disease-free survival (DFS), and death from any cause for overall survival (OS). Results: Of the 360 patients initially enrolled, 356 were evaluated as the modified intention-to-treat population (n = 178 in both groups). A total of 311 patients underwent surgery and pCR was achieved in 80 patients, another 10 patients undergo a watch-and-wait approach after achieving cCR. With a median follow-up time of 48 months (Q25-Q75, 41-55 months), 57 deaths (33 and 24), 17 local failures (11 and 6) and 69 distant metastases (37 and 32) were observed, respectively. Overall, the 4y LC rate were 93% and 96% in control and experimental groups, with estimated LC HR of 0.53 (95% confidence interval [CI], 0.20-1.43), the 4y DFS rates were 69% and 74% (HR = 0.74, 95% CI 0.49-1.10), and the 4y OS were 80% and 85%, (HR = 0.70, 95% CI 0.42-1.19), respectively. In the subgroup analysis, irinotecan showed a significant improvement in DFS (HR = 0.77, 95% CI 0.61-0.98) and OS (HR = 0.71, 95% CI 0.51-0.98) in UGT1A1 *1*1 patients. Conclusions: The addition of irinotecan to standard capecitabine-based CRT had a tendency towards improving LC, DFS, and OS, but without reaching statistical significance. UGT1A1 *1*1 patients seem to benefit the most from irinotecan. Molecular studies and subsequent therapies should be considered. Clinical trial information: NCT02605265.

Improved Survival in Acute Myeloid Leukaemia Patients Aged over 40 Given Cladribine in Combination with Standard Remission Induction (DA 3+7) and Consolidation Treatment (HD AraC). Seven Year Follow-Up of Prospective, Cooperative PALG Study.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2003-2003
Author(s):  
Jerzy Holowiecki ◽  
Sebastian Grosicki ◽  
Andrzej Hellmann ◽  
Aleksander Skotnicki ◽  
Tadeusz Robak ◽  
...  
Keyword(s):  
Present Report ◽  
Remission Induction ◽  
Induction Treatment ◽  
Consolidation Therapy ◽  
Term Outcome ◽  
Long Term Outcome ◽  
The Difference ◽  
Acute Myeloid

Abstract The aim of this study was to evaluate long-term outcome of acute myeloid leukemia (AML) patients treated within the PALG 1999 DAC vs. DA Study. [b][Within 3 years (1999–2002) 445 patients, aged 18–60, were randomized 1:1 to the induction treatment DAC-7: daunorubicin 60 mg/m2/d iv 1–3; cytarabine 200 mg/m2/d ci d 1–7; cladribine (2-CdA) 5 mg/m2 2h inf. iv d 1–5 and standard DA-7 regimen (the same therapy excluding cladribine). Patients achieving CR received two courses of subsequent intensive consolidation: HAM (HD AraC, mitoxantrone) HD AraC with or without cladribine in the DAC-7 or DA-7 arm, respectively. In case of PR after the first induction course the same regimen was repeated, Post-consolidation therapy was comparable in both arms with following proportions of autoHCT, alloHCT and maintenance: DAC-7 17%, 14%, 69%; DA-7 21%, 14%, 65%, respectively. As previously reported, a single course of DAC-7 induction resulted in 17% higher CR rate compared to the DA-7 treatment (p=0,0008). The difference was particularly pronounced in patients: aged >40 years and with initial WBC >100x109/L. In the latter subgroup also the overall CR rate (achieved after entire induction program) was higher in the DAC-7 arm (71% vs. 43%). [Leukemia.2004;18:989–97] In the present report we analyzed seven-year long-term outcome (median follow-up 5 yrs) in the whole study population and in subgroups stratified according to age, initial WBC, cytogenetics, sex, FAB subtype, and preceding myelodysplasia. In the whole group the overall survival (OS) rate equaled 29,5% for DAC-7 and 24% for DA-7 arm (p=NS) and leukemia free survivall (LFS) 30% vs. 28% (p=NS), respectively. Of note, in patients aged >40 years, the therapy containing cladribine was associated with improved OS (26% vs. 14,5%, p=0.03), and LFS (28% for DAC-7 vs. 18,5% for DA-7, p=0.02). Other subgroup analyses revealed higher probability of the OS in patients with initial WBC ≥ 50 G/l assigned to DAC-7 compared to DA-7 arm (32% vs. 20,5%, p=0.04). The LFS rate equaled 35% and 27% (p=NS), respectively. In women receiving DAC-7 induction therapy in comparison with those treated in arm without 2-CdA reached higher OS: 29% vs. 19,5%, p=0,03, respectively. LFS in these subgroups was comparable: 25% vs. 22%, p=NS, respectively. We conclude that addition of cladribine to induction and consolidation therapy of AML improves long-term outcome in patients: older than 40 y, as well as in those with high tumour burden. The better outcome in older patients results mainly from reduced risk of relapse, whether that in cases with high WBC seems to be linked to a higher CR rate.

Thalidomide / Dexamethasone (TD) Vs. Bortezomib (Velcade)â/Thalidomide / Dexamethasone (VTD) Vs. VBMCP/VBAD/Velcadeâ as Induction Regimens Prior Autologous Stem Cell Transplantation (ASCT) in Multiple Myeloma (MM): Results of a Phase III PETHEMA/GEM Trial.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 130-130 ◽  
Author(s):  
Laura Rosiñol ◽  
Ma Teresa Cibeira ◽  
Joaquin Martinez ◽  
Maria Victoria Mateos ◽  
Albert Oriol ◽  
...  
Keyword(s):  
High Risk ◽  
Induction Therapy ◽  
High Risk Group ◽  
Phase Iii ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Phase Iii Trial ◽  
Grade 3

Abstract Abstract 130 In April 2006, the Spanish Myeloma Group (PETHEMA/GEM) activated a randomized phase III trial comparing TD vs. VTD vs. VBMCP/VBAD/Velcadeâ in patients 65 years-old or younger with newly diagnosed symptomatic MM, followed by ASCT with MEL-200. The primary end points were response rate after induction and after ASCT and time to progression. TD consisted of thalidomide 200 mg daily (escalating doses in the first cycle) and dexamethasone 40 mg on days 1–4 and 9–12 at 4-week intervals for 6 cycles. The VTD regimen was identical to TD plus Velcade 1.3 mg/m2 on days 1,4,8,11 of each cycle. Combination chemotherapy plus Velcadeâ consisted of 4 cycles of VBMCP/VBAD on an alternating basis followed by 2 cycles of Velcadeâ (1.3 mg/m2 on days 1,4,8, and 11 every 3 weeks). The duration of the induction therapy was 24 weeks in all arms. From April 6, 2006 to August 5, 2009 the 390 planned patients entered the study. As of December 31, 2008, 305 patients (median age: 57 yrs, M: 156, F:149; IgG. 181, IgA: 71, light chain: 43, others: 10) entered the study and are the basis of the current analysis. Fifty-six (18%) patients had soft-tissue extramedullary plasmacytomas (EMP) and the stage according to the ISS was I in 39%, II in 41 %, III in 19 % and unknown in 1%. The prognostic factors, including cytogenetics, was similar in the 3 arms. Fifty-five (18%) patients had high-risk cytogenetics (t(4;14), t(14;16) and/or 17p deletion). Two-hundred and ninety-nine patients (TD:103, VTD: 99 and VBMCP/VBAD/Velcade®: 97) were evaluable for response and toxicity to induction therapy. The ≥ PR rate was 64%, 82% and 75% with TD, VTD and VBMCP/VBAD/Velcade®, respectively (p=NS). The IF negative CR rate was significantly higher with VTD (29%) and with VBMCP/VBAD/Velcade® (25%) than with TD (14%) (p=0.009 and p=0.04, respectively). Progressive disease (PD) was significantly higher with TD than with VTD (21% vs. 8%, p=0.009). In the overall series, PD was significanty higher in patients with EMP (34% vs. 12%, p=0.0002) with a significanty higher PD rate for TD as compared with VTD (40% vs. 14%, p=0.05). In patients with poor cytogenetics the CR rate was significantly higher with VTD than with TD (42% vs. 5%, p=0.009). In this high-risk group the PD rate was higher with TD (37%) and with VBMCP/VBAD/Velcade® (23%) than with VTD (0%) (p=0.009 and p=0.04, respectively). The incidence of thrombotic events ≥ grade 3 was higher in the TD arm (9% vs. 1% vs. 3%, p=0.07 and p=0.01) while ≥3 peripheral neuropathy was higher with VTD (14% vs. 0% and 1%, p<0.0001 and p=0.0003). Treatment was discontinued due to toxicity in 11 patients (TD: 3, VTD: 6, VBMCP/VBAD/Velcade®:2). Eight patients died during induction period (TD:5, VTD: 2, VBMCP/VBAD/Velcade®: 1) One-hundred seventy-seven patients were evaluable for response after ASCT. The post-ASCT CR rate with TD, VTD and VBMCP/VBAD/Velcade® was 40%, 59% and 48%, respectively, being significantly higher with VTD than with TD (p=0.05). The estimated overall survival at 2 years is 82% with no significant differences among the 3 arms. TTP and PFS were significantly shorter with TD (p=0.05 and p=0.012, respectively). In summary, VTD results in a higher pre- and post-ASCT CR rate as well as in a lower PD rate than TD, particularly in patients with high-risk cytogenetics or with EMP. The TTP and PFS are shorter with TD. Intermediate results are observed with VBMCP/VBAD/Velcade®. Longer follow-up is needed to establish whether or not these results will translate into a significantly different long-term outcome. Updated data will be presented at the meeting. Disclosures: Rosiñol: Janssen-Cilag: Honoraria; Celgene: Honoraria. Off Label Use: Thalidomide and bortezomib are not yet approved in Spain. Cibeira:Jansse-Cilag: Honoraria; Celgene: Honoraria. Mateos:Janssen-Cilag: Honoraria; Celgene: Honoraria. Oriol:Janssen-Cilag: Honoraria; Celgene: Honoraria. García-Laraña:Janssen-Cilag: Honoraria; Celgene: Honoraria. de la Rubia:Janssen-Cilag: Honoraria; Celgene: Honoraria. Sureda:Janssen-Cilag: Honoraria; Celgene: Honoraria. Palomera:Janssen-Cilag: Honoraria; Celgene: Honoraria. Díaz-Mediavilla:Janssen-Cilag: Honoraria; Celgene: Honoraria. de Arriba:Janssen-Cilag: Honoraria; Celgene: Honoraria. Alegre:Janssen-Cilag: Honoraria; Celgene: Honoraria. Lahuerta:Janssen-Cilag: Honoraria; Celgene: Honoraria. San Miguel:Janssen-Cilag: Honoraria; Celgene: Honoraria. Blade:Janssen-Cilag: Honoraria; Celgene: Honoraria.

Long-term outcome of laminectomy for cervical ossification of the posterior longitudinal ligament

2013 ◽  
Vol 18 (5) ◽  
pp. 465-471 ◽  
Author(s):  
Soo Eon Lee ◽  
Chun Kee Chung ◽  
Tae-Ahn Jahng ◽  
Hyun-Jib Kim
Keyword(s):  
Recovery Rate ◽  
Statistical Significance ◽  
Japanese Orthopaedic Association ◽  
Posterior Longitudinal Ligament ◽  
Clinical Impression ◽  
Term Outcome ◽  
Long Term Outcome ◽  
The Mean

Object Although laminectomy is an effective surgical technique for the treatment of multilevel cervical stenotic lesions, postoperative kyphosis and neurological deterioration have been frequently reported after laminectomy. Hence, laminectomy without fusion is seldom performed nowadays. However, the clinical impression from the long-term follow-up of patients who had undergone laminectomy does not support that postoperative kyphosis is common in patients with ossification of the posterior longitudinal ligament (OPLL). In this paper, the authors assessed the long-term outcome of laminectomy for cervical OPLL in terms of the changes in the cervical curvature and in the neurological status. Methods The authors retrospectively reviewed medical records and radiological images in patients who had undergone cervical laminectomy between 1999 and 2009. The preoperative and the final follow-up status recovery rate were assessed using the Japanese Orthopaedic Association (JOA) scale. The cervical global angle and range of motion (ROM) were measured preoperatively and at the last follow-up. The cervical spine was classified into 3 types: lordotic, straight, and kyphotic. Results A total of 34 patients were available for medical record review and telephone interviews. There were 28 men and 6 women, whose mean age at the time of surgery was 57.8 years. The mean follow-up period was 57.5 months. The mean preoperative JOA score was 10.7, and the JOA score at the last follow-up was significantly improved to 14.3 (p < 0.001) with a recovery rate of 56.3%. The JOA score at each postoperative follow-up point increased until 6 years postoperatively; thereafter, it gradually decreased. The mean preoperative global angle was −11.3° and the most recent global angle was −8.4°. The preoperative ROM was 33.9° and the most recent ROM was 27.4°. There was no statistical significance in the change of cervical curvature or ROM. Preoperatively, 29 of the 34 patients had a lordotic cervical curvature and 5 patients had a straight spine. At last follow-up, 24 patients had a lordotic curvature, 3 patients changed from lordosis to kyphosis, and 7 patients had a straight spine. One patient whose cervical curvature changed from lordosis to kyphosis during the follow-up period underwent cervical fusion 9 years after the laminectomy procedure. Conclusions The long-term outcome of laminectomy for cervical OPLL is satisfactory in terms of the clinical and radiological aspects. The risk of postlaminectomy kyphosis was not high, raising the possibility that the OPLL itself may serve as a support for the spinal column.

Long-Term Outcome of Facial Growth after Functional Endoscopic Sinus Surgery

2002 ◽  
Vol 126 (6) ◽  
pp. 628-634 ◽  
Author(s):  
Marcella R. Bothwell ◽  
Jay F. Piccirillo ◽  
Rodney P. Lusk ◽  
Brock D. Ridenour
Keyword(s):  
Statistical Significance ◽  
Tertiary Care ◽  
Sinus Surgery ◽  
Care Hospital ◽  
Facial Growth ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Facial Plastic

OBJECTIVE: We sought to determine whether functional endoscopic sinus (FES) surgery performed in children with chronic rhinosinusitis alters facial growth. STUDY DESIGN AND SETTING: This was a retrospective age-matched cohort outcome study performed at a tertiary care hospital. RESULTS: Sixty-seven children participated. There were 46 boys and 21 girls, and the mean age was 3.1 years at presentation and 13.2 years at follow-up. There were 46 children who underwent FES surgery and 21 children who did not undergo FES surgery. Quantitative anthropomorphic analysis was performed using 12 standard facial measurements. A facial plastic expert performed qualitative facial analysis. Both quantitative and qualitative analyses showed no statistical significance in facial growth between children who underwent FES surgery and those who did not undergo FES surgery. CONCLUSIONS: In this study, there was no evidence that FES surgery affected facial growth. SIGNIFICANCE: These results will aid physicians when discussing with parents the risks of FES surgery.

LONG-TERM Outcome of a Fondazione Italiana Linfomi Study Comparing Short Rituximab Maintenance Vs Observation after Brief First-LINE R-FND Chemoimmunotherapy Followed By Rituximab Consolidation in Elderly Patients with Advanced Follicular Lymphoma (FL)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3985-3985
Author(s):  
Carola Boccomini ◽  
Marco Ladetto ◽  
Francesca Dutto ◽  
Simone Ferrero ◽  
Luca Baldini ◽  
...  
Keyword(s):  
High Risk ◽  
Low Risk ◽  
First Line ◽  
Term Outcome ◽  
Long Term Outcome ◽  
High Risk Patients ◽  
Rituximab Maintenance ◽  
Risk Patients

Abstract Introduction: we previously reported (Vitolo U, JCO 2013) the results of a randomized study with brief first-line chemoimmunotherapy followed by rituximab maintenance vs observation. With a median follow-up of 42 months, 3-year Progression Free Survival (PFS) and Overall Survival (OS) were 66% and 89%, respectively. The addition of Rituximab maintenance gave a benefit to the patients: 2-year PFS was 81% for rituximab maintenance versus 69% for observation with a HR of 0.63 (95% CI: 0.38-1.05, p=0.079), although not statistically significant. Moreover we also found that achievement of Minimal Residual Disease (MRD) negativity predicted a better PFS: 3-year PFS 72% vs 39%, HR 3.1 (Ladetto M, Blood 2013). Overall these data showed the good efficacy of this brief chemoimmunotherapy regimen in elderly FL patients. Aim of this analysis was to report long-term outcome and long-term toxicities of this regimen. Methods: From January 2004 to December 2007, 242 treatment-naive patients aged 60-75 years with FL Grade I, II and IIIa were enrolled by 33 FIL centres. Patients had to have advanced (high tumor burden stage II or stage III-IV) disease requiring treatment: 4 monthly courses of R-FND (standard doses of Rituximab, Fludarabine, Mitoxantrone, Dexamethasone) every 28 days followed by 4 weekly Rituximab infusions as consolidation. Responders patients [complete remission (CR) + unconfirmed CR + partial remission (PR)] were randomized to brief rituximab maintenance (Arm A), once every 2 months for a total of 4 doses, or observation (Arm B). MRD for the bcl-2/IgH translocation was determined on bone marrow cells in a centralized laboratory belonging to Euro-MRD consortium, using qualitative and quantitative PCR. Results: a total of 234 patients began chemoimmunotherapy: after induction and consolidation treatment overall response rate was 86%, with 69% CR. Of these, 210 completed the planned treatment and 202 responders were randomized. Up to date, median follow-up were 96 months from enrollment and 87 months from randomization; additional follow-up data were available for 127/146 (87%) not relapsed/progressed patients. Five- and 7-year PFS for the whole population were 57% and 51%, respectively; 5- and 7-year OS for the whole population were 85% and 80%, respectively. From enrollment, an advantage in term of PFS and also OS was observed in FLIPI low risk patients: 7-year PFS was 67% for low risk versus 38% for intermediate-high risk patients (p<0.001) and 7-year OS was 86% versus 75%, respectively (p=0.03). After randomization, no differences between the two arms were detected for both PFS and for OS at 5 (data not showed) and 7 years: 7-year PFS was 55% for rituximab maintenance arm versus 52% for observation arm (p=0.331; HR 0.8); 7-year OS was 83% for both arms (p=0.208; HR 0.67). Moreover, after randomization no differences between the two arms were detected for both FLIPI low risk and intermediate-high risk patients: 7-year PFS was 67% for Rituximab maintenance arm versus 68% for observation arm (p=0.808) in low risk patients; in intermediate-high risk patients 7-year PFS was 46% vs 35% (p=0.301), respectively in Arm A vs B. Conversion to PCR negativity at the end of treatment maintains predictive value for better PFS: 7-year PFS were 58% and 36% (p=0.084), respectively for MRD negative vs positive patients. The same risk of late toxicity (infections or cardiac events) or secondary cancers was observed in both arms: in particular, 13 secondary neoplasms in maintenance arm vs 16 in observation arm were recorded. Conclusions: the present long-term results of this trial with a prolonged follow-up of 7 years confirm that a good outcome is achievable in elderly FL patients with a short-term chemoimmunotherapy (R-FND + Rituximab consolidation) with a 7-year PFS of 51% and low toxicity. In addition these results did not show clear evidence in favor of a shortened Rituximab maintenance after R-fludarabine containing chemotherapy. Conversely, the achievement of PCR negativity maintains predictive value for a better outcome. Figure 1. Figure 1. Disclosures Off Label Use: Rituximab maintenance was not licensed in first-line treatment for follicular lymphoma at that time in Italy; Rituximab was provided free by Roche.

Klinische Langzeitergebnisse der perkutanen transluminalen Angioplastie bei Patienten mit peripherer arterieller Verschlusskrankheit

VASA ◽  
2002 ◽  
Vol 31 (1) ◽  
pp. 36-42 ◽  
Author(s):  
. Bucek ◽  
Hudak ◽  
Schnürer ◽  
Ahmadi ◽  
Wolfram ◽  
...  
Keyword(s):  
Success Rate ◽  
Clinical Stage ◽  
Ankle Brachial Index ◽  
Clinical Situation ◽  
Clinical Results ◽  
Transluminal Angioplasty ◽  
Term Outcome ◽  
Long Term Outcome

Background: We investigated the long-term clinical results of percutaneous transluminal angioplasty (PTA) in patients with peripheral arterial occlusive disease (PAOD) and the influence of different parameters on the primary success rate, the rate of complications and the long-term outcome. Patients and methods: We reviewed clinical and hemodynamic follow-up data of 166 consecutive patients treated with PTA in 1987 in our department. Results: PTA improved the clinical situation in 79.4% of patients with iliac lesions and in 88.3% of patients with femoro-popliteal lesions. The clinical stage and ankle brachial index (ABI) post-interventional could be improved significantly (each P < 0,001), the same results were observed at the end of follow-up (each P < 0,001). Major complications occurred in 11 patients (6.6%). The rate of primary clinical long-term success for suprainguinal lesions was 55% and 38% after 5 and 10 years (femoro-popliteal 44% and 33%), respectively, the corresponding data for secondary clinical long-term success were 63% and 56% (60% and 55%). Older age (P = 0,017) and lower ABI pre-interventional (P = 0,019) significantly deteriorated primary clinical long-term success for suprainguinal lesions, while no factor could be identified influencing the outcome of femoro-popliteal lesions significantly. Conclusion: Besides an acceptable success rate with a low rate of severe complications, our results demonstrate favourable long-term clinical results of PTA in patients with PAOD.

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