Retrospective analysis of patients with sentinel lymph node (SLN) positive melanoma (MEL) who received adjuvant nivolumab (NIVO) without completion lymph node dissection (CLND).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9590-9590
Author(s):  
Zeynep Eroglu ◽  
Nalan Babacan ◽  
Kenneth F. Grossmann ◽  
Joseph Markowitz ◽  
Andrew Scott Brohl ◽  
...  
Keyword(s):  
Lymph Node ◽  
Retrospective Analysis ◽  
Nodal Basin ◽  
Grade 3 ◽  
One Year ◽  
In Transit ◽  
Braf Mutant ◽  
Disease Free ◽  
Free Rate

9590 Background: Until recently, most patients (pts) with SLN+ MEL underwent CLND, a procedure mandated in published trials of adjuvant anti-PD-1 therapy to date. Following MSLT-II, this practice has dramatically changed with most pts now undergoing surveillance or adjuvant therapy without CLND. In addition, pts with in-transit/satellite MEL were excluded or not reported in these prior adjuvant studies. Our aim was to explore real-world outcomes of adjuvant NIVO in these pts. Methods: We carried out a single center retrospective analysis of stage 3 MEL pts who received adjuvant NIVO. Results: 32 pts with SLN+ MEL who did not undergo a CLND and started adjuvant NIVO within 3 months of surgery were included. Median age was 60 (26-77); per AJCC v7, 12 pts had Stage 3A, 11 stage 3B, and 9 pts had Stage 3C MEL. One was acral MEL; 18 had an ulcerated primary. 6 pts had BRAF-mutant MEL, 20 had BRAF-WT, and 6 unknown. NIVO treatment was 240 mg Q2wks or 480 mg Q4wks, up to one year. 21 pts developed grade 1/2 immune-related adverse events (irAEs), and 1 pt stopped NIVO due to toxicity (fatigue). With median follow-up of 7 months, only 1 pt had a recurrence, which was in the in SLN+ nodal basin; pt was rendered disease-free with surgery. The relapse-free rate (RFS) rate at 1 year was 95% (95% CI, 71-100). Of 21 pts with in-transit/satellite recurrent MEL (median age 68 [29-84]) who started adjuvant NIVO (no prior drug treatment), 5 had BRAF-mutant MEL, 14 BRAF-WT, 2 unknown; two were acral-lentiginous. 3 pts had recurrences: 2 regional and 1 distant mets, treated with surgery, TVEC, or BRAF-targeted therapy. Median follow-up was 8 months from NIVO start; 1-year RFS was 72% (95% CI 32-91). 15 pts developed irAEs; in 12, these were grade 1-2 and in 3, were grade 3 that led to discontinuation. Conclusions: While preliminary, these findings suggest that adjuvant anti-PD-1 therapy may be effective in SLN+ pts who forego CLND prior to adjuvant treatment, as 1-year RFS rate appears similar to rates in the published adjuvant anti-PD-1 trials that mandated CLND. This therapy may be similarly effective in pts with resected in-transit/satellite stage 3 melanoma. Further follow-up will be presented.

Isolated same-basin lymph node recurrence after precision lymph node excision for clinically evident melanoma metastasis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9576-9576
Author(s):  
Kevin Lynch ◽  
Yinin Hu ◽  
Norma Farrow ◽  
Yun Song ◽  
Max Meneveau ◽  
...  
Keyword(s):  
Lymph Node ◽  
Disease Control ◽  
Lymph Node Dissection ◽  
Patient Preference ◽  
Distant Metastases ◽  
Node Dissection ◽  
Melanoma Patients ◽  
Regional Disease ◽  
In Transit

9576 Background: While management of the nodal basin for melanoma has largely moved to observation for microscopic sentinel lymph node (SLN) metastasis, complete lymph node dissection (CLND) remains the current standard of care for melanoma patients with macroscopic, clinically detectable lymph node metastases (cLN). As CLND is associated with high surgical morbidity, we sought to study whether cLN may be safely managed by excision of only clinically abnormal nodes (precision lymph node dissection, PLND). Currently, a small subset of patients with cLN do not undergo CLND because of frailty or patient preference. We hypothesized that in these selected patients, PLND would provide acceptable regional control rates. Methods: Retrospective chart review was conducted at four academic tertiary care hospitals to identify melanoma patients who underwent PLND for cLN. cLN were defined as palpable or radiographically abnormal nodes. Recurrences were categorized as local/in-transit, same-basin lymph node, or distal lymph node/visceral. The primary outcome was isolated same-basin recurrence after PLND. Results: Twenty-one patients underwent PLND for cLN without synchronous distant metastases (characteristics of primary lesions summarized in Table). Reasons for forgoing CLND included patient preference (n=8), imaging indeterminate for distant metastases (n=2), comorbidities (n=4), loss to follow up (n=1), partial response to checkpoint blockade (n=1), or not reported (n=5). The inguinal node basin was the most common site (n=10), followed by the axillary (n=8) and cervical basins (n=3). A median of 2 nodes were resected at PLND, and 68% of resected nodes were positive for melanoma (median: 1, range: 1-3 nodes). Median follow-up was 23 months from PLND, and recurrence was observed in 28.6% of patients overall. Only 1 patient (4.8%) developed an isolated same-basin recurrence. The 3-year cumulative incidence of isolated same-basin recurrence was 5.3%, while risk of isolated local/in-transit recurrence or distant basin/visceral metastasis were 19.8% and 33.3%, respectively. Complications from PLND were reported in 1 patient (4.8%) and were limited to post-operative seroma and lymphedema. Conclusions: These pilot data suggest that PLND may offer acceptable regional disease control for cLN. Post-operative morbidity from PLND was also low, raising the possibility that PLND may provide adequate regional disease control without the morbidity associated with CLND. These data justify additional, prospective evaluation of PLND in selected patients.[Table: see text]

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.

A pilot study of topotecan in the treatment of serous carcinoma of the uterus

2003 ◽  
Vol 13 (2) ◽  
pp. 216-222
Author(s):  
J. T. Chambers ◽  
T. J. Rutherford ◽  
P. E. Schwartz ◽  
M. L. Carcangiu ◽  
S. K. Chambers ◽  
...  
Keyword(s):  
Pilot Study ◽  
Topoisomerase I ◽  
Residual Disease ◽  
Serous Carcinoma ◽  
Hematologic Toxicity ◽  
First Line ◽  
Uterine Serous Carcinoma ◽  
Grade 3 ◽  
Disease Free

A pilot study investigated topotecan (Hycamtin, GlaxoSmithKline, Philadelphia, PA), a topoisomerase I inhibitor, in treating uterine serous carcinoma, a typically unresponsive aggressive tumor. Fifteen patients were surgically staged, then treated with topotecan (1.5 mg/m2, Days 1–5 every 21 days) as first-line therapy (n = 12) or secondary to platinum failure (n = 3). Patients received topotecan through six courses, disease progression, or unacceptable toxicity. Grade 3/4 hematologic toxicity prompted dose adjustments. Thirteen patients exhibited no gross evidence of residual disease postoperatively. At topotecan initiation, one patient had 5-cm and one had < 1-cm residual disease. Seventy-eight courses (median, six) were administered; 12 (80%) patients completed the specified protocol. Common serious toxicities included grade 3 neutropenia (33%), anemia (13%), and thrombocytopenia (13%). Eight patients received erythropoietin and/or granulocyte colony-stimulating factor. Median follow-up for 14 evaluable patients was 26 months (range, 13–40). Of 11 evaluable first-line topotecan patients, nine were alive at follow-up; five were disease-free. Of three second-line topotecan patients, two died and one was alive with disease 31 months post-treatment. One patient with measurable disease achieved a complete and one a partial response as assessed by computed tomography scan. Median progression-free survival was 25 months; median survival has not been reached at 26 months. Although topotecan's antitumor activity cannot yet be quantified, disease-free interval and survival outcomes compare favorably with other therapies in uterine serous carcinoma. Further evaluation of topotecan in this population is warranted.

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.

Long-Term Disease-Free Survival of Patients with AML Relapse After T-Cell-Depleted Allogeneic Stem Cell Transplantation by Re-Induction Therapy and Subsequent Interferon-Boosted Donor Lymphocyte Infusion

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3064-3064
Author(s):  
M. Eefting ◽  
C.J.M. Halkes ◽  
S. Kersting ◽  
W.A.F. Marijt ◽  
P.A. von dem Borne ◽  
...  
Keyword(s):  
Immune Response ◽  
Induction Therapy ◽  
Acute Gvhd ◽  
Disease Free Survival ◽  
Remission Induction ◽  
Free Survival ◽  
Grade 3 ◽  
Disease Free

Abstract Abstract 3064 Relapse of AML after allogeneic stem cell transplantation (alloSCT) has a very poor prognosis. Salvage re-induction chemotherapy leads to clinical remissions in a substantial number of patients, but these remissions tend to be of short duration. In contrast, donor lymphocyte infusions (DLI) have the potential to effect long-lasting remissions, but the interval of several weeks to months that is required to develop a DLI-induced anti-leukemia response may prevent efficient control of a highly proliferative leukemia. In addition, a high tumor burden may suppress the immune response. In contrast, the combination of efficient cytoreduction by chemotherapy with DLI administered in rapid succession under circumstances favoring the development of an early and profound immune response might have the potential to eradicate otherwise resistant leukemia cells. We therefore adopted an institutional therapeutic strategy for relapsed myeloid leukemia post-allogeneic SCT based on administration of DLI at the anticipated end of the neutropenic phase after salvage re-induction chemotherapy. At this time point, the high prevalence of a pro-inflammatory milieu should favor the induction of the immune response, and an expected state of lymphopenia should promote the expansion of infused T cells by homeostatic proliferation. If 3 weeks after DLI no graft versus host disease (GvHD) was observed, the potential anti-leukemia immune response was further amplified by treatment with interferon- α (IFN- α) until GvHD occurred. Between January 2000 and December 2009 44 patients with relapsed myeloid malignancy after alloSCT were treated at our hospital. Pre-transplant diagnoses were AML n=40, CMML n=1 and MDS n=3. Median time from SCT to relapse was 187 days. Median follow-up after relapse was 3.1 years. 5 patients had a smouldering relapse (<10% bone marrow blasts) and 39 patients had an overt relapse. Of 39 patients with overt relapse, 7 patients (18%) did not receive re-induction therapy due to poor performance status (n=5) or patient choice (n=2). 32 patients received remission-induction therapy consisting of gemtuzumab ozogamycin (n=9), cytosine arabinoside-containing chemotherapy (n=17), or both (n=6). Following this treatment, 7 of 32 patients had rapidly progressive disease during induction therapy (n=6) or died due to toxicity (n=1) and did not receive DLI. The remaining 25 patients received DLI at a dose of 5.0×10 ^6 CD3+ cells/kg for related and 2.5×10 ^6 CD3+ cells/kg for unrelated donors 3 weeks after the start of remission-induction therapy. In 16 of these patients DLI was boosted with IFN- α 3.0×10 ^6 IE once daily. This strategy resulted in acute GvHD in 17 of 25 patients (n=8 grade 1–2, n=9 grade 3–4). At 6 weeks after DLI, 16 patients had reached CR, 5 patients had failed to reach CR (2 with GvHD) and 4 suffered treatment-related mortality (3 with GvHD). Of the 16 patients in CR, 4 had no signs of GvHD and developed a second relapse during the follow-up period. Only 3 of 12 patients in CR with signs of acute GvHD at 6 weeks after DLI developed a second relapse. In total, 9 of 17 patients (53%) with acute GvHD after DLI had long term survival versus none without acute GvHD. During follow-up, 8 patients developed chronic GvHD (n=4 limited, n=4 extensive). Finally, 5 patients with an early detected smouldering relapse received DLI, which was boosted with IFN- α in 2 patients, without salvage re-induction therapy. All 5 patients developed GvHD (n=2 grade 1–2, n=3 grade 3–4) and 3 patients achieved a CR of whom 1 patient died from GvHD. Our results indicate that treatment of relapsed AML after alloSCT with salvage re-induction therapy followed by DLI at the end of the neutropenic phase during minimal residual disease, with additional boosting of the immune response with IFN- α, can result in long-term disease-free survival. Disclosures: Off Label Use: Interferon: DLI-boosting.

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 phase II evaluation of aerosolized GM-CSF (AGM-CSF) plus standard I-MAP/ GM-CSF/MAP/ surgery/ irradiation in the reduction of pulmonary metastases (P-METS) in soft tissue sarcoma (STS) patients (PTS)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 10058-10058
Author(s):  
S. H. Okuno ◽  
M. R. Mahoney ◽  
B. F. Kabat ◽  
R. M. Marks ◽  
W. J. Maples ◽  
...  
Keyword(s):  
Pulmonary Metastases ◽  
Treatment Sequence ◽  
Debulking Surgery ◽  
Gm Csf ◽  
Median Size ◽  
Proximal Extremity ◽  
Ecog Ps ◽  
Disease Free ◽  
Free Rate

10058 Background: P-METs remain illusive with standard treatments for STS. AGM-CSF demonstrated tolerability with promising efficacy in reducing P-METS. We evaluated the 2-yr P-MET free rate in chemonaiive pts with extremity STS. Methods: ECOG PS 0/1 and Gr 3/4 primary STS of the limb girdle/extremities, were required. Treatment sequence: 2 cycles of IMAP (Ifosfamide, Mitomycin, Doxorubicin, Cisplatin) plus s.q. GM-CSF (preload d -6 to -3, d1–14); MAP (d0, 28) during irradiation (d1–35) plus AGM-CSF 250 mcg bid (d1–7, 15- 22, 28–35); surgery; post-op irradiation plus AGM-CSF 250 mcg bid (d1–7, 15–22, 28–35, 42–49). 6 of 35 pts with P-METS in ≤ 2 yrs implied lack of efficacy w.r.t. reducing P-METS. Results: 38 eligible pts were enrolled (20 male, median age 51 yrs, 24 PS 0). Median size of tumor 9 cm (2.3–26.7 cm).Location of tumors included: proximal extremity-16, distal extremity-11, and limb girdle-12. 79% received debulking surgery; 29 rendered disease-free. 38 pts are evaluable for toxicity (see table ). More common Gr 3+ events related to treatment appear below. 79% had Gr 4 neutropenia, despite s.q. GM-CSF. 6 pts have died, with 2.5 yrs median follow-up on survivors (range .4- 4.6). No treatment related fatalities occurred. 10 pts had P-METS ≤ 2 yrs. The estimated 2 yr P-MET free rate is 75% (95% CI 62–91). Conclusions: Although high, neutropenia was as expected. AGM-CSF failed to improve the 2 yr P-MET free rate in this group of STS pts. Other strategies need to be explored. Supported by NIH Grant CA15083–32 and Berlex Corporation. Max Severity (Gr 3+) [Table: see text] No significant financial relationships to disclose.

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.

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