Clinical experience with different dosing schedules of decitabine in patients with myelodysplastic syndromes (MDS)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7011-7011
Author(s):  
D. Steensma ◽  
H. Kantarjian ◽  
P. Wijermans
Keyword(s):  
De Novo ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Two Phase ◽  
Dosing Schedule ◽  
Transfusion Independence ◽  
Improved Outcomes ◽  
Dosing Regimens ◽  
Number Of Treatment

7011 Background: Decitabine, a potent DNA hypomethylating agent, has demonstrated efficacy in MDS patients using two dosing regimens: 15 mg/m2 intravenous (IV) over 3 hours (hrs) every (q) 8 hrs for 3 days q 6 weeks (wks) and 20 mg/m2 IV over 1 hr once daily for 5 consecutive days q 4 wks. Methods: Results were reviewed from two randomized phase 3 studies comparing the 3-day dosing schedule of decitabine with supportive care, D-0007 and EORTC-06011, and two phase 2 studies with the 5-day dosing schedule, DACO-020 and ID03–0180. Data from each clinical trial supporting overall improvement, duration of improvement, time to AML or death, progression-free survival (PFS), and transfusion independence was assessed. Results: Patients had IPSS classification scores of intermediate-2 or high-risk (D-0007, 70%; EORTC-06011, 93%; ID03–0180, 66%; DACO-020, 46%) and de novo MDS (D-0007, 87%; EORTC-06011, 88%; ID03–0180, 70%; DACO-020, 89%). Comparable overall improvement (complete response [CR] + partial response [PR] + hematologic improvement [HI]), time to AML or death, and PFS was observed across all trials (Table). The duration of improvement ranged between 9.2 and 11.3 months. A trend was observed for improved outcomes with an increased number of decitabine treatment cycles. Conclusions: Overall improvement rates by IWG criteria exceeded 30% in all 4 studies. Higher overall improvement rates corresponded to increased median number of treatment cycles. Increasing the number of decitabine treatment cycles administered may provide additional benefit to MDS patients. [Table: see text] [Table: see text]

scholarly journals DDRE-12. PNOC001 (NCT01734512): A PHASE II STUDY OF EVEROLIMUS FOR RECURRENT OR PROGRESSIVE PEDIATRIC LOW-GRADE GLIOMAS (pLGG)

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii63-ii64
Author(s):  
Sabine Mueller ◽  
Mariam Aboian ◽  
Kellie Nazemi ◽  
Karen Gauvain ◽  
Janet Yoon ◽  
...  
Keyword(s):  
Molecular Analysis ◽  
Predictive Biomarkers ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Low Grade ◽  
Stage Design ◽  
Entire Cohort ◽  
Ribosomal Protein S6 ◽  
Number Of Treatment

Abstract OBJECTIVE To estimate the 6-month Progression Free Survival (PFS6) associated with everolimus for progressive/recurrent pLGGs and to determine if activated PI3K/Akt/mTOR pathway as measured by positive phosphorylated-ribosomal protein S6 (p-RPS6) status was associated with response. METHOD Patients 3–21 years of age with recurrent or progressive pLGG were enrolled. Everolimus was administered orally at 5 mg/m2 daily. Tissue availability for molecular analysis was mandatory. Immunohistochemistry (IHC) for p-RPS6 was performed centrally. An adaptive Simon two-stage design was employed based on p-RPS6 status. Based on results of the first stage, enrollment in the second stage was either limited to pathway activated patients or open to all subjects. RESULTS From December 2012 to July 2019 a total of 65 subjects enrolled [median age 9 years (range 3–19); 43% female]. As of December 15, 2019 median number of treatment cycle is 8 (range 1–24); 7 patients remain on treatment. Toxicity profile is similar to published reports with rash and elevated lipid profiles as most common adverse events. PFS6 for the entire cohort is 63%; PFS6 is 64% for the activated and 61% for the non-activated patients. Central imaging review (n=52) revealed 1 partial response, 1 complete response, 33 stable disease, and 17 progressive disease at the end of study treatment. Initial molecular analysis identified BRAF alterations in 35/65 patients. CONCLUSION Everolimus is well tolerated and active in a subset of pLGGs. Ongoing analyses will assess predictive biomarkers of response and will be reported at the meeting.

scholarly journals LGG-53. PNOC001 (NCT01734512): A PHASE II STUDY OF EVEROLIMUS FOR RECURRENT OR PROGRESSIVE PEDIATRIC LOW-GRADE GLIOMAS (pLGG)

2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii376-iii376
Author(s):  
Sabine Mueller ◽  
Mariam Aboian ◽  
Kellie Nazemi ◽  
Karen Gauvain ◽  
Janet Yoon ◽  
...  
Keyword(s):  
Molecular Analysis ◽  
Predictive Biomarkers ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Low Grade ◽  
Entire Cohort ◽  
Ribosomal Protein S6 ◽  
Response Method ◽  
Number Of Treatment

Abstract OBJECTIVE To estimate the 6-month Progression Free Survival (PFS6) associated with everolimus for progressive/recurrent pLGGs and to determine if activated PI3K/Akt/mTOR pathway as measured by positive phosphorylated-ribosomal protein S6 (p-RPS6) status was associated with response. METHOD: Patients 3–21 years of age with recurrent or progressive pLGG were enrolled. Everolimus was administered orally at 5 mg/m2 daily. Tissue availability for molecular analysis was mandatory. Immunohistochemistry (IHC) for p-RPS6 was performed centrally. An adaptive Simon two-stage design was employed based on p-RPS6 status. Based on results of the first stage, enrollment in the second stage was either limited to pathway activated patients or open to all subjects. RESULTS From December 2012 to July 2019 a total of 65 subjects enrolled [median age 9 years (range 3–19); 43% female]. As of December 15, 2019 median number of treatment cycle is 8 (range 1–24); 7 patients remain on treatment. Toxicity profile is similar to published reports with rash and elevated lipid profiles as most common adverse events. PFS6 for the entire cohort is 63%; PFS6 is 64% for the activated and 61% for the non-activated patients. Central imaging review (n=52) revealed 1 partial response, 1 complete response, 33 stable disease, and 17 progressive disease at the end of study treatment. Initial molecular analysis identified BRAF alterations in 35/65 patients. CONCLUSION Everolimus is well tolerated and active in a subset of pLGGs. Ongoing analyses will assess predictive biomarkers of response and will be reported at the meeting.

Investigate the efficacy of immunotherapy for treatment of pancreatic adenocarcinoma (PDAC) with mismatch repair deficiency (dMMR).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 415-415
Author(s):  
Arish Noor ◽  
Luis E. Aguirre ◽  
Kirsten Blue ◽  
Trenton Avriett ◽  
Estrella M. Carballido ◽  
...  
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Metastatic Disease ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Cancer Center ◽  
Duration Of Response

415 Background: Immune checkpoint inhibitors (ICI) have been approved in solid tumors with dMMR. However, only limited data are available for PDAC with dMMR given the rarity of dMMR in PDAC. We evaluated efficacy of ICIs in PDAC with dMMR. Methods: Retrospective clinical and pathologic data were collected for patients (pts) with pancreatic adenocarcinoma from May 2017 to June 2020 at Moffitt cancer center. Results: We identified 10 pts with dMMR PDAC. The median age was 64.5 years (range: 42-86) and 4 pts were male. 4 pts had resectable disease, 3 had locally advanced and 3 had metastatic disease at initial diagnosis. MSH6 deficiency (def) was found in 2 cases, PMS2 def in 2, MLH/PMS2 def in 5, and MSH2/MSH6 in 1. 7 pts were treated with ICIs. 3 pts had locally advanced and 4 had metastatic disease when they started ICIs. 5 received Pembrolizumab (pem), 1 received ipilimumab/ nivolumab (ipi/nivo), and 1 received pem then ipi/nivo after progressive disease (PD) on pem. The median number of prior lines of chemotherapy was 1 (range 0-2). 6 pts were evaluable, and 1 had rapid disease progression after 1 dose of pem. Among 6 evaluable pts, 3 had an objective response (1: complete response and 2: partial response), and 2 had stable disease (SD). Median progression-free survival was 8.2 mo, and median overall survival was not reached with median follow-up (FU) of 6.8 mo. The median duration of response was not reached with a median FU of 22.6 mo. The pt with CR remained disease-free for up to 22 months. The pt whose treatment was switched to ipi/nivo after PD on pem achieved SD > 4mo on ipi/nivo. While on immunotherapy, one patient with ipi/nivo developed immunotherapy associated rash requiring systemic steroids, and another on pem developed hypothyroidism requiring levothyroxine. Conclusions: This series suggest ICIs can provide durable clinical efficacy in pts with dMMR PDAC.

Outcome of neoadjuvant chemotherapy (NACT) with paclitaxel plus carboplatin and oral metronomic chemotherapy (OMCT) in patients with technically unresectable oral cavity squamous cell carcinoma (SCC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18034-e18034
Author(s):  
Lakhan Kashyap ◽  
Vijay Maruti Patil ◽  
Sachin Dhumal ◽  
Vanita Noronha ◽  
Amit Joshi ◽  
...  
Keyword(s):  
Oral Cavity ◽  
Infratemporal Fossa ◽  
Pathologic Complete Response ◽  
Metronomic Chemotherapy ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Oral Tongue ◽  
Resection Rate ◽  
Kaplan Meier

e18034 Background: NACT is often used in technically unresectable oral cavity SCC to improve resection rate. NACT regimen based on combination of maximum tolerated doses (MTD) and metronomic chemotherapy will debulk the tumor and subsequently inhibit angiogenesis which may overcome drug resistance of MTD schedule. We assessed outcome and tolerance of this combination as NACT in patients with technically unresectable oral cavity SCC. Methods: This is retrospective analysis of prospectively maintained data. Fourteen patients having technically unresectable oral cavity SCC received NACT with paclitaxel (175mg/m2) plus carboplatin (AUC5) every 3 weekly (MTD schedule) and OMCT (methotrexate 9mg/m2 once a week, celecoxib 200mg twice daily and erlotinib 150mg once daily). Patient were assessed clinically and radiologically after minimum of two cycles for surgery. Kaplan-Meier method was used for survival analysis. We report resectability, survival and tolerance of this regimen. Results: Median age of the patients was 38 years, and twelve patients (85%) were male. Twelve (85%) and two (15%) patients had buccal mucosa and oral tongue primary, respectively. AJCC 2017 stage IVA and IVB disease was present in twelve (85%) and two (15%) patients, respectively. Reason for technical unresectabilty was skin edema above zygoma in five (36%), high infratemporal fossa involvement in five (36%), nodal encasement of major vessels in two (14%) and posterior extent of oral tongue tumor into oropharynx in two (14%) patients. Median number of NACT administered were three. Tumor of nine patients (65%; 95% CI = 39%-89%) were deemed resectable after NACT. Eight patients underwent surgery and tumor of one patient showed pathologic complete response. Median follow up was 14.6 months (95% CI = 14.1 - 15 months). Median progression free survival was 11.4 months (95% CI = 7.9 – 15 months). Median overall survival (OS) was not reached while OS at 15 months was 63.5% (95% CI = 37.8% - 89.2%). Common grade 3/4 toxicities (CTCAE 5.0) were neutropenia in eight (57%), thrombocytopenia in three (21%), febrile neutropenia, hypokalemia and diarrhoea in two patients (14%) each. Two patients required in-patient supportive care for adverse events. Conclusions: Paclitaxel and carboplatin along with OMCT is well tolerated and less resource intensive regimen which leads to favorable resection rate and survival in patients with technically unresectable oral cavity SCC.

Phase II Activity of Belinostat (PXD-101), Carboplatin, and Paclitaxel in Women With Previously Treated Ovarian Cancer

2012 ◽  
Vol 22 (6) ◽  
pp. 979-986 ◽  
Author(s):  
Don S. Dizon ◽  
Lars Damstrup ◽  
Neil J. Finkler ◽  
Ulrik Lassen ◽  
Paul Celano ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Confidence Interval ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Clinical Activity ◽  
Phase 2 ◽  
Resistant Disease ◽  
Novel Approach

BackgroundPreclinical data show that belinostat (Bel) is synergistic with carboplatin and paclitaxel in ovarian cancer. To further evaluate the clinical activity of belinostat, carboplatin, and paclitaxel (BelCaP), a phase 1b/2 study was performed, with an exploratory phase 2 expansion planned specifically for women with recurrent epithelial ovarian cancer (EOC).MethodsThirty-five women were treated on the phase 2 expansion cohort. BelCap was given as follows: belinostat, 1000 mg/m2 daily for 5 days with carboplatin, AUC 5; and paclitaxel, 175 mg/m2 given on day 3 of a 21-day cycle. The primary end point was overall response rate (ORR), using a Simon 2 stage design.ResultsThe median age was 60 years (range, 39–80 years), and patients had received a median of 3 prior regimens (range, 1–4). Fifty-four percent had received more than two prior platinum-based combinations, sixteen patients (46%) had primary platinum-resistant disease, whereas 19 patients (54%) recurred within 6 months of their most recent platinum treatment. The median number of cycles of BelCaP administered was 6 (range, 1–23). Three patients had a complete response, and 12 had a partial response, for an ORR of 43% (95% confidence interval, 26%–61%). When stratified by primary platinum status, the ORR was 44% among resistant patients and 63% among sensitive patients. The most common drug-related adverse events related to BelCaP were nausea (83%), fatigue (74%), vomiting (63%), alopecia (57%), and diarrhea (37%). With a median follow-up of 4 months (range, 0–23.3 months), 6-month progression-free survival is 48% (95% confidence interval, 31%–66%). Median overall survival was not reached during study follow-up.ConclusionsBelinostat, carboplatin, and paclitaxel combined was reasonably well tolerated and demonstrated clinical benefit in heavily-pretreated patients with EOC. The addition of belinostat to this platinum-based regimen represents a novel approach to EOC therapy and warrants further exploration.

Results of the Initial Treatment Phase of a Study of Three Alternative Dosing Schedules of Azacitidine (Vidaza®) in Patients with Myelodysplastic Syndromes (MDS).

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 819-819 ◽  
Author(s):  
Roger M. Lyons ◽  
Thomas Cosgriff ◽  
Sanjiv Modi ◽  
Heidi McIntyre ◽  
Indra Fernando ◽  
...  
Keyword(s):  
Maintenance Phase ◽  
Treatment Phase ◽  
Median Number ◽  
Low Risk ◽  
Open Label ◽  
Dosing Schedule ◽  
Transfusion Independence ◽  
Best Response ◽  
To Receive ◽  
Rbc Transfusion

Abstract Background: Azacitidine (Vidaza®) is an effective and safe treatment (Tx) for patients (pts) with MDS (JCO2002;20:2429) at a dosing schedule of 75 mg/m²/day SC for 7 days every 4 weeks. A dosing schedule eliminating the need for weekend administration would be more convenient to pts and clinicians. Reported here are results of the recently completed initial Tx phase (6 cycles of randomized Tx) of an ongoing study evaluating 3 alternative azacitidine dosing schedules. Methods: In this phase II multicenter, open-label trial, MDS pts were randomized to 1 of 3 regimens administered every 4 weeks for 6 cycles: AZA 5-2-2 (75 mg/m²/day x 5 days, followed by 2 days no Tx, followed by 75 mg/m²/day x 2 days); AZA 5-2-5 (50 mg/m²/day x 5 days, followed by 2 days no Tx, followed by 50 mg/m²/day x 5 days); or AZA 5 (75 mg/m²/day x 5 days). Major and minor hematologic improvements (HI) were assessed by International Working Group (IWG) criteria (Blood2000;96:3671) and pts with ≥56 Tx days were IWG evaluable. To determine whether therapeutic response is maintained after 6 cycles, a 12-month maintenance phase using the AZA-5 regimen administered every 4 or 6 weeks was added, and pts with at least stable disease were eligible to participate in that phase of the study. Results: A total of 151 pts were randomized to Tx with AZA 5-2-2 (n=50), AZA 5-2-5 (n=51), or AZA 5 (n=50). Most pts are FAB classification RA/RARS (57%) or RAEB (30%). Of the 139 pts (92%) who received ≥56 days of Tx and are IWG evaluable, 74 pts (49%) completed ≥6 Tx cycles. The median number of Tx cycles across all Tx arms was 6. Of IWG-evaluable pts, 71 (51%) experienced HI (Table). The proportions of red blood cell (RBC) transfusion-dependent pts who achieved transfusion independence were AZA 5-2-2: 55% (12/22), AZA 5-2-5: 60% (12/20), and AZA-5: 67% (16/24). In FAB low-risk (RA/RARS) transfusion-dependent pts at baseline, RBC transfusion independence was reached by 60% (9/15), 56% (5/9), and 61% (11/18), respectively. No Tx-related mortality has been reported. Most grades 3 and 4 Tx-related AEs were hematological (AZA 5-2-2: 44%, AZA 5-2-5: 33%, AZA 5: 18%). Conclusions: Independent of the alternative dosing regimen, the results of the initial 6-cycle Tx phase demonstrate a consistent response for HI, RBC transfusion independence, and safety profile across a broad range of MDS pts, including FAB low-risk pts. These results appear similar to those with the approved FDA regimen and further support the benefit of azacitidine in pts who are transfusion-dependent. Eligible pts continue to receive Tx during the ongoing 12-month maintenance phase of the study. Major Hematologic Improvement in IWG Evaluable Pts (N=139) Major HI AZA 5-2-2 (N=46) AZA 5-2-5 (N=44) AZA 5 (N=49) *Includes major and minor HI; pts counted only once for best response in an improvement category. n (%) (95% CI) n (%) (95% CI) n (%) (95% CI) Erythroid 15 (33) (20, 48) 17 (39) (24, 55) 19 (39) (25, 54) Platelet 10 (22) (11, 36) 8 (18) (8, 33) 9 (18) (9, 32) Neutrophil 3 (7) (29, 100) 4 (9) (40, 100) 4 (8) (40, 100) Any HI* 20 (44) (29, 59) 23 (52) (37, 68) 28 (57) (42, 71)

Clinical Efficacy of VEL-CTD (Bortezomib, Cyclophosphamide, Thalidomide, and Dexamethasone) Regimen in Patients with Relapsed or Refractory Multiple Myeloma: A Phase II Study

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3693-3693
Author(s):  
Yeo-Kyeoung Kim ◽  
Je-Jung Lee ◽  
Sang-Kyun Sohn ◽  
Ho-Jin Shin ◽  
Joo-Seop Chung ◽  
...  
Keyword(s):  
Sensory Neuropathy ◽  
Previous Treatment ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Chemotherapeutic Agents ◽  
Significant Activity ◽  
Treatment Regimens ◽  
Highly Active ◽  
Therapeutic Responses

Abstract BACKGROUND: Recent studies demonstrates that the combination of bortezomib and several chemotherapeutic agents may have significant activity in myeloma. In this study, we assessed the efficacy and safety of the combination with bortezomib, cyclophosphamide, thalidomide, and dexamethasone (vel-CTD) for the patients with relapsed/refractory myeloma. METHODS: Fifty-three patients who had received at least four cycles of treatment were enrolled. Bortezomib was given at 1.3 mg/m2 on D1, 4, 8, 11, thalidomide 50 mg/day, daily, cyclophosphamide 150 mg/m2 P.O. on D1–4, and dexamethasone 20 mg/m2 I.V. or P.O. on D1, 4, 8, 11. RESULTS: There were 26 males (49.1%) and 27 females (50.9%). The median age of patients was 67 years (range, 40–78 years). Median number of the previous treatment regimens was two (range, 1~5). Of total 53 patients, forty-nine patients (92.5%) achieved at least a partial response (PR) including 28 (52.8%) with complete response (CR) and 21 (42.9%) with PR as their best response. Median progression-free survival (PFS) was 14.7 months (range; 12.3–17.1 months) and median overall survival (OS), from the onset of vel-CTD was 31.6 months (range; 23.3–39.9 months). Patients who achieved a good response at least a PR after four cycles of vel-CTD showed longer PFS than those with poor therapeutic responses (2yr PFS, 28±8.7% vs. 0%, p=0.03). Further, patients who achieved a good therapeutic responses also showed significantly longer OS than those with poor responses (2yr OS, 72.3±8.3% vs. 33.3±15.7%, p=0.009). Grade 3–4 toxicities included thrombocytopenia (30.2%), neutropenia (11.3%), peripheral sensory neuropathy (32.1%), and thrombosis (3.8%). There was no treatment-related death. CONCLUSIONS: Vel-CTD is a highly active salvage therapy in patients with relapsed/refractory myeloma. However, frequent side effects such as peripheral neuropathy should be considered. Furthermore, trials evaluating novel treatment approaches after bortezomib should be offered to reduce the rate of disease progression, particularly in patients who fail to show a good response at least PR after four cycles of therapy.

Novel organic arsenic molecule darinaparsin: Development of IV and oral forms

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 8501-8501 ◽  
Author(s):  
I. Lossos ◽  
M. D. Craig ◽  
M. S. Tallman ◽  
R. V. Boccia ◽  
P. R. Conkling ◽  
...  
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Complete Response ◽  
Median Number ◽  
Two Phase ◽  
Phase I Studies ◽  
Advanced Malignancies

8501 Background: Darinaparsin (ZIO-101) is a novel organic arsenical active against diverse cancers in vitro, and in vivo. Darinaparsin i.v. activity in lymphoma is being evaluated in a phase II study. Darinaparsin is orally bioavailable; the oral form is being investigated in two phase I studies in patients with advanced malignancies. Methods: Phase II trial is being conducted in patients diagnosed with advanced lymphomas who had ≥ 1 prior therapy. Patients receive 300 mg/m2/day of darinaparsin i.v. for 5 consecutive days every 28 days. Efficacy and safety are evaluated by standard criteria. Phase I oral dose escalation studies are being conducted in patients with advanced malignancies and explore safety, MTD, DLTs and preliminary efficacy of continuous and intermittent dosing schedules. Starting continuous dose is 100 mg BID for 3 weeks with 1 week rest, starting intermittent dose is 300 mg twice weekly for 3 weeks followed by 1 week rest. Results: The phase II study has accrued 28 lymphoma patients (21 non-Hodgkin's, 7 Hodgkin's); median age at baseline 61 years, ECOG ≤2, median number of prior therapies 3. Seventeen subjects have received at least 2 cycles of darinaparsin and are evaluable for efficacy. Of these, 1 subject (PTCL) has achieved a complete response, 3 - partial responses (2 marginal zone, 1 Hodgkin's), and 4 stable disease (2 PTCL, 1 DLBCL, 1 Hodgkin's). A total of 63 cycles of darinaparsin have been administered to subjects with lymphoma. No Gr. 3 or higher drug-related AEs were reported. Two SAEs were considered possibly drug-related (fall; neutropenic fever). Phase I studies accrued 35 patients; median age at baseline 58 years, ECOG ≤2, median number of prior therapies 3. Predominant tumor types include: colorectal (17), pancreatic (3), NHL (3). Current darinaparsin dose levels: continuous 200 mg BID, 2× weekly 900 mg. Of 18 patients evaluable for efficacy, 10 demonstrate SD ≥ 3 cycles. Oral darinaparsin bioavailability is 58%. Drug-related AEs include nausea/vomiting, fatigue, decreased appetite/anorexia. Conclusions: Darinaparsin is active in heavily pretreated patients with advanced lymphoma and has been very well tolerated. Oral darinaparsin is also well tolerated, and shows early activity. [Table: see text]

Neoadjuvant chemotherapy for locally advanced cervical cancer: Experience at the Instituto Oncologico Nacional SOLCA Guayaquil.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15571-e15571
Author(s):  
Guillermo Paulson ◽  
Katherine Garcia ◽  
Mayra Santacruz ◽  
Ruth Ginger Engracia ◽  
Jose Francisco Mendoza
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Invasive Cervical Cancer ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Number Of Cycles ◽  
Clinical Records ◽  
Cancer Experience

e15571 Background: Cervical cancer is the most common malignancy of women in Ecuador. The main problem of concomitant chemo-radiotherapy (CRT) is the delay in starting radiation therapy, economic and logistical problems for high demand in radiotherapy. It has been neoadjuvant chemotherapy (NACT) followed by CRT the main treatment at our center in order to find an alternative to long waits before the start of radiotherapy. The aim of this study was to determine the response to NACT followed by CRT in terms progression-free survival (PFS) and overall survival (OS). Methods: diagnosed with invasive cervical cancer locally advanced stage II-III were analyzed retrospectively reviewed clinical records of pre-existing data from 2008 to 2010. Results: after meeting the criteria of exclusion, leaving 116 cases. The median age: 49 years (range: 28-82 years). The histology was 73% (85) squamous cell carcinoma, 26% (30) adenocarcinoma and 0.9% (1) not specified. Patients with stage IIB: 81.9% (95), IIIA: 10.3% (12), IIIB: 7.8% (9). Of the 116 patients 69% (80) received NACT. The main NACT was paclitaxel 175mg/m2 + Cisplatin 75mg/m2 every 3 weeks 63.8% (74), the remaining group received another protocol, the median number of cycles of NACT was 5 (1 - 8 cycles), the start of radiotherapy since the conclusion of NACT was 53 days on average (1 to 285 days) and the main regimen of CRT concomitant was cisplatin 40mg/m2 weekly 47.5% (38). In the 49 patients who underwent NACT followed by CRT, a radiological study showed, complete response (CR) 38.8% (19), 18.4% partial response (PR) (9), disease progression (DP) 12.2% (6), stable disease (SD) 8.2% (4) and the end of treatment evaluation gynecological was performed and CR was obtained in 59.2% (29). Persistent or progressive disease after treatment was 22.4% (11), recurrence was 12.2% (6), local recurrence 2.0% (1), distant metastasis 10.2% (5). OS of NACT followed by CRT was 93.9% (46) and PFS was 65.3% (32), OS after CR was 96% (25 / 1) and then 91.7% PR (24 / 2) with p: 0.439. Conclusions: NACT followed by CRT is a valid option because it improves disease-related symptoms, but OS did not improve significantly even after CR.

Efficacy and safety of amrubicin in patients with advanced or recurrent thymoma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e17513-e17513
Author(s):  
Kiyotaka Yoh ◽  
Koichi Goto ◽  
Seiji Niho ◽  
Shigeki Umemura ◽  
Hironobu Ohmatsu ◽  
...  
Keyword(s):  
Tumor Size ◽  
Single Agent ◽  
Reduction Rate ◽  
Progression Free Survival ◽  
Median Number ◽  
Significant Activity ◽  
Efficacy And Safety ◽  
Kaplan Meier ◽  
Grade 3 ◽  
Number Of Treatment

e17513 Background: Thymoma is rare thoracic tumor, which is chemoresponsive with anthracycline or cisplatin-containing regimen in advanced or recurrent setting. Amrubicin is a novel anthracycline agent that is well known to exert significant activity against small-cell lung cancer. The purpose of this study was to determine the efficacy and safety of amrubicin in patients with advanced or recurrent thymoma. Methods: We reviewed 11 consecutive patients with advanced or recurrent thymoma treated with single-agent amrubicin therapy at our institution from May 2006 to September 2010, retrospectively. Amrubicin was administered intravenously at 40 or 45 mg/m2 on day 1 to 3 of 3-4 weeks until disease progression or development of intolerance. Results: Profile of patients included: median age was 57 years (range 25–74); Male/Female=5/6; PS 0/1= 7/4; and Masaoka stage IVA/IVB/recurrence=7/2/2. All patients had received no prior chemotherapy. The median number of treatment cycles was 4 (range 3-6). A partial response was achieved in 1 patient and 10 patients exhibited stable disease. The overall response rate was 9%, but 3 patients had at least a 20% reduction in tumor size with amrubicin. The median reduction rate in tumor size was 13% (range 0-40). The median progression-free survival period was 5.4 months (range 2.3-15.8 months). The median overall survival has not been reached although a median follow-up time was 2.5 years. Based on the Kaplan-Meier method, the estimated 3-year survival rate was 83%. The most common adverse events were hematological toxicities. Five patients had grade 3/4 neutropenia, but febrile neutropenia was not observed. Non-hematological grade 3 toxicities were less frequent. There were no treatment-related deaths. Conclusions: Single-agent amrubicin showed modest activity and acceptable safety profile as chemotherapy for advanced or recurrent thymoma. Additional testing of amrubicin combined with cisplatin in this disease is warranted.

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