Treatment of chemotherapy-induced breakthrough nauea and vomiting

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20536-e20536 ◽  
Author(s):  
R. M. Navari ◽  
S. E. Gray
Keyword(s):  
Serotonin Receptor ◽  
Rescue Therapy ◽  
Performance Status ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Ecog Performance Status ◽  
Difficult Situation ◽  
Serotonin Receptor Antagonists ◽  
Drug Classes ◽  
To Receive

e20536 Background: Patients may experience breakthrough nausea and vomiting (BNV) despite adequate prophylaxis for chemotherapy-induced nausea and vomiting (CINV). BNV presents a difficult situation as treatment of ongoing nausea and vomiting is challenging. We investigated three different drug classes for the treatment of BNV: phenothiazines (prochlorperazine)(Pro), dopamine-serotonin receptor antagonists (metoclopramide) (Meto), and a corticosteroid-thiobenzodiazepine combination (dexamethasone plus atypical antipsychotic olanzapine) (Dex-Olan). Methods: Adult patients, receiving moderately emetogenic chemotherapy and CINV prophylaxis with a 5-hydroxytryptamine-3 receptor antagonist and Dex pre-chemotherapy and Dex post-chemotherapy according to ASCO guidelines, who experienced BNV during the five days post-chemotherapy were randomized to receive Pro, 10 mg IV, and 10 mg, po, bid for three days; Meto, 20 mg IV, and 10 mg, po, bid for 3 days; or Dex, 20 mg IV and Olan, 5 mg, po, bid for three days. All patients also received at least one liter of IV fluids during the IV phase of their treatment. Patients were excluded if they had undergone rescue therapy with any of the study agents. Beginning with the first day of treatment for BNV (day 1) and daily through day 5, patients recorded episodes of vomiting/retching, nausea, other symptoms utilizing the M.D. Anderson Symptom Inventory, and the utilization of any additional rescue therapy. One hundred six patients (median age 61, range 37 - 85, 60 males, ECOG performance status ≤ 2) consented to the protocol and 100 were evaluable. Results: A complete response (no emesis, no additional rescue) for the five days post-initiation of BNV treatment was recorded for 7 of 35 patients (20%) in the Pro regimen, 12 of 33 patients (36%) receiving the Meto regimen, and 21 of 32 patients (66%) receiving the Dex-Olan regimen. There were no Grade III or IV treatment related toxicities. Conclusion: The combination of Dex-Olan was an effective treatment for BNV and was significantly more effective than Pro or Meto alone. No significant financial relationships to disclose.

Biomarker testing patterns and actionability in advanced non-small cell lung cancer (aNSCLC) at OneOncology (OneOnc).

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 287-287
Author(s):  
Ari M. Vanderwalde ◽  
Esprit Ma ◽  
Elaine Yu ◽  
Tania Szado ◽  
Richard Price ◽  
...  
Keyword(s):  
Performance Status ◽  
Ecog Performance Status ◽  
Personalized Care ◽  
Specimen Collection ◽  
Targeted Treatments ◽  
Biomarker Testing ◽  
Next Generation Sequencing Ngs ◽  
To Receive ◽  
Testing Patterns ◽  
Test Result

287 Background: Recent approvals of targeted treatments (tx) have improved personalized care in aNSCLC. Biomarker testing is crucial for patients (pts) to receive optimal tx expeditiously. This study examined aNSCLC biomarker testing and tx patterns at OneOnc. Methods: Pts diagnosed with aNSCLC (stage ≥ IIIb) from 1/1/2015 to 5/31/2020, aged ≥ 18 years, and with ≥ 1 visit ≤ 90 days of advanced (Adv) diagnosis (Dx) were retrospectively evaluated using the nationwide Flatiron Health electronic health record derived de-identified database from selected OneOnc sites. Descriptive analyses were conducted to evaluate testing patterns for ALK, BRAF, EGFR, KRAS, PD-L1, and ROS-1 biomarkers and actionable mutation tx pattern. Results: Overall 3,860 aNSCLC pts were included, median age was 69 years, 47% females, 66% non-squamous, 29% squamous, 4% histology NOS, and 23% with ECOG performance status 0-1. Of the 3,152 (82%) pts tested for any biomarker, 64% received next-generation sequencing (NGS) vs. 36% received other biomarker tests only. Testing rates varied by biomarker: EGFR (74%), ALK (72%), ROS-1 (66%), PD-L1 (57%), BRAF (56%), KRAS (54%). Pts who received all 6 biomarker tests increased from 12% (2015), 23% (2016), 40% (2017), 41% (2018), 48% (2019) to 56% (2020). Among the tested pts, the median time from Adv Dx to the first test result was 20 days (d) and from specimen collection after Adv Dx to the first test result was 12 d. Pts tested and treated before test result available declined from 28% (2015) to 16% (2020). Of 1,207 pts with actionable mutations, 390 (32%) received tx before the test result: 35% chemotherapy (chemo) only, 28% chemo + cancer immunotherapy (CIT), and 15% CIT only. After the test result, 26% to 81% of pts received no or other tx not specific to actionable mutations [Table]. Conclusions: Findings from this study demonstrated an increase in aNSCLC biomarker testing at OneOnc over time, while 44% pts in 2020 did not receive testing on all 6 biomarkers. Some pts had tx prior to the test result, but this trend appeared to decline. Further studies are warranted to better understand the reasons for pts receiving tx that were not specific to their actionable mutations.[Table: see text]

Nivolumab (NIVO) plus ipilimumab (IPI) versus chemotherapy (chemo) as first-line (1L) treatment for advanced non-small cell lung cancer (NSCLC): 4-year update from CheckMate 227.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9016-9016
Author(s):  
Luis G. Paz-Ares ◽  
Tudor-Eliade Ciuleanu ◽  
Jong-Seok Lee ◽  
Laszlo Urban ◽  
Reyes Bernabe Caro ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Performance Status ◽  
Stage Iv ◽  
Ecog Performance Status ◽  
Programmed Death ◽  
Long Term Follow Up ◽  
To Receive ◽  
Clinical Trial Information

9016 Background: 1L NIVO + IPI was shown to provide durable long-term overall survival (OS) benefit vs chemo regardless of tumor programmed death ligand 1 (PD-L1) expression in patients (pts) with advanced NSCLC in CheckMate 227 Part 1 (NCT02477826); 3-year OS rates were 33% vs 22% in pts with PD-L1 ≥ 1% (HR, 0.79 [95% CI, 0.67–0.93]) and 34% vs 15% in pts with PD-L1 < 1% (HR, 0.64 [95% CI, 0.51–0.81]). Here we report updated results from the study with 4 years’ minimum follow-up. Methods: Adults with previously untreated stage IV / recurrent NSCLC, no known EGFR/ ALK alterations , and ECOG performance status ≤ 1 were enrolled; pts were stratified by squamous (SQ) and non-squamous (NSQ) histology. Pts with PD-L1 ≥ 1% (n = 1189) were randomized 1:1:1 to receive NIVO (3 mg/kg Q2W) + IPI (1 mg/kg Q6W), NIVO alone (240 mg Q2W), or chemo. Pts with PD-L1 < 1% (n = 550) were randomized 1:1:1 to receive NIVO + IPI, NIVO (360 mg Q3W) + chemo, or chemo. OS with NIVO + IPI vs chemo in pts with PD-L1 ≥ 1% was the primary endpoint. Results: With minimum follow-up of 49.4 months (database lock, Feb 18, 2021), pts were at least 2 years beyond the protocol-specified end of immunotherapy treatment. Pts with PD-L1 ≥ 1% continued to show durable benefit with NIVO + IPI vs chemo (HR, 0.76 [95% CI, 0.65–0.90]); 4-year OS rates were 29% (NIVO + IPI), 21% (NIVO), and 18% (chemo). At 4 years, 14% (NIVO + IPI), 10% (NIVO), and 4% (chemo) remained progression free. Among responders, 34%, 30%, and 7% remained in response, respectively. In an exploratory analysis in pts with PD-L1 ≥ 50%, 4-year OS rates were 37% (NIVO + IPI), 26% (NIVO), and 20% (chemo). In pts with PD-L1 < 1%, OS HR for NIVO + IPI vs chemo was 0.64 (95% CI, 0.51–0.81); 4-year OS rates were 24% (NIVO + IPI), 13% (NIVO + chemo) and 10% (chemo). At 4 years, 12% (NIVO + IPI), 7% (NIVO + chemo), and 0% (chemo) remained progression free. Among responders, 31%, 13%, and 0% remained in response, respectively. Among pts who progressed on NIVO + IPI vs chemo, 7% vs 40% (PD-L1 ≥ 1%), and 9% vs 33% (PD-L1 < 1%), received subsequent immunotherapy. Benefit with NIVO + IPI vs chemo was observed for both SQ and NSQ histology (Table). With long-term follow-up, no new safety signals were identified. Conclusions: With 4 years’ minimum follow-up, 1L NIVO + IPI continued to provide durable, long-term OS benefit vs chemo in pts with advanced NSCLC regardless of PD-L1 expression or histology. Clinical trial information: NCT02477826. [Table: see text]

Addition of the Oral NK1 Antagonist Aprepitant to Standard Antiemetics Provides Protection Against Nausea and Vomiting During Multiple Cycles of Cisplatin-Based Chemotherapy

2003 ◽  
Vol 21 (22) ◽  
pp. 4105-4111 ◽  
Author(s):  
R. de Wit ◽  
J. Herrstedt ◽  
B. Rapoport ◽  
A.D. Carides ◽  
G. Carides ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Therapy Group ◽  
Rescue Therapy ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Cumulative Probability ◽  
Pharmacokinetic Data ◽  
Standard Therapy Group ◽  
Nk1 Antagonist ◽  
Multiple Cycles

Purpose: This analysis evaluated whether the antiemetic efficacy of the NK1 receptor antagonist aprepitant (EMEND™, Merck, Whitehouse Station, NJ) plus standard antiemetics could be sustained for up to six cycles of cisplatin-based chemotherapy. Patients and Methods: Patients receiving cisplatin ≥ 70 mg/m2 were blindly assigned to receive one of the following three regimens: (1) aprepitant 375 mg 1 hour before cisplatin on day 1 and aprepitant 250 mg on days 2 to 5 (n = 35); (2) aprepitant 125 mg before cisplatin and aprepitant 80 mg on days 2 to 5 (n = 81); or (3) placebo before cisplatin on days 2 to 5 (n = 86). All groups received ondansetron 32 mg and dexamethasone 20 mg before cisplatin, and dexamethasone 8 mg on days 2 to 5. The primary end point was complete response (no emesis and no rescue therapy) over 5 days following cisplatin in up to six cycles. A cumulative probability analysis using a model for transitional probabilities was used to analyze the data. The aprepitant 375/250-mg regimen was discontinued early in light of new pharmacokinetic data. Results: In the first cycle, 64% of patients in the aprepitant group and 49% in the standard therapy group had a complete response. Thereafter, complete response rates for the aprepitant group were still 59% by cycle 6, but decreased to 34% by cycle 6 for the standard therapy group. Reasons for discontinuation were similar across treatment groups. Conclusion: Compared with patients who received standard therapy, those who received only the aprepitant regimen had better and more sustained protection against chemotherapy-induced nausea and vomiting over multiple cycles.

Phase II Study of Gemtuzumab Ozogamycin (GO) and Cytarabine (ARA-C) in Patients with High Risk MDS and AML..

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4723-4723
Author(s):  
Peter Kang ◽  
Karen Seiter ◽  
Delong Liu ◽  
Muhammad Arshad ◽  
Anila Qureshi ◽  
...  
Keyword(s):  
High Risk ◽  
Performance Status ◽  
Poor Performance ◽  
Complete Response ◽  
Lung Damage ◽  
Poor Performance Status ◽  
High Cumulative Dose ◽  
History Of ◽  
M 12 ◽  
To Receive

Abstract To evaluate the efficacy of GO + ara-c in high risk pts, we treated 22 pts with MDS (10) and AML (12) with cytarabine 100 mg/m2/d x 7 d and GO 9 mg/m2 x 1 on d 4. Pts with MDS were eligible if they had [1] RAEB-1 and either hgb &lt; 8 gm/dl, platelet &lt; 50,000/mm3, neutrophils &lt; 1000/mm3, or cytogenetics other than 5q-, 20q-, -y, or normal, [2] RAEB-2, or [3] CMML. Pts with AML (newly diagnosed or relapsed) were eligible if they were ineligible for anthracycline-based therapy (poor performance status: 2 pts; low ejection fraction or high cumulative dose of anthracyclines: 6 pts, both reasons: 4 pts). The median age was 66, M:12, F:10. Diagnoses: RAEB-1: 4, RAEB-2: 5, CMML: 1, AML, newly dx’d: 7, AML relapsed: 5. Cytogenetics were high risk: 10, intermediate risk: 11 pts, low risk: 1 pt. Overall, 18% had a complete response (CR) after one cycle of therapy. Three pts (14%) had a partial response (PR), of which one had a CR after a second course of therapy. Of the pts with AML: CR: 2/12, PR: 2/12, Failure (F): 5/12, Toxic Death (TD): 3/12. For pts with MDS: CR: 2/10, PR: 1/10, F: 5/10, TD: 2/10. Toxicities included neutropenic fever/sepsis, mucositis, diarrhea, increased LFTs, hemorrhage. One pt with a history of ABVD and RT to chest for HD developed direct pulmonary toxicity due to chemotherapy (diffuse pulmonary infiltrates, biopsy proven toxic lung damage). Although overall response rate is modest, some pts had remarkable responses: One pt with RAEB-1, transfusion dependent and multiple high risk cytogenetics (−5, −7, multiple others) remains in CR (including cytogenetic CR) 7 months post treatment. A second pt with RAEB-1, transfusion dependent and multiple high risk cytogenetics (−5, −7, multiple others) had a PR after one course, but was unable to receive further chemotherapy due to toxicity. The latter pts suggest that this regimen should be studied further in pts with MDS, poor risk cytogenetics and low blast counts.

Rituximab® and High Dose Methylprednisolone (HDMP) for the Treatment of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2518-2518
Author(s):  
Januario E. Castro ◽  
Jan Bole ◽  
Carlos E. Prada ◽  
Thomas J. Kipps
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Performance Status ◽  
Variable Region ◽  
Response Assessment ◽  
Complete Response ◽  
Lymphocytic Leukemia ◽  
High Dose ◽  
Ecog Performance Status ◽  
Female Ratio ◽  
High Dose Methylprednisolone

Abstract High-dose gluocorticoids and the anti-CD20 mAb Rituximab each can effect partial responses in patients with chronic lymphocytic leukemia (CLL), although complete and durable responses to treatment with either of these agents have not been reported. We examined whether patients with relapsed and/or refractory CLL could respond to these agents when used in combination in a pilot clinical trial. Fourteen patients with progressive, symptomatic, and relapsed/refractory disease were treated with three four-week cycles of high-dose Methylprednisolone (HDMP) at 1gr/m2 daily for 5 days and weekly Rituximab® at 375mg/m2 for four weeks. The median age of the patients was 60 years, the male to female ratio was 4:1, the ECOG performance status was &lt; 2, and the average number of prior treatments was 2. All patients failed or were intolerant to fludarabine and 86% had high-risk disease by the modified Rai classification. Sixty-five percent of the patients had CLL cells that expressed ZAP-70 and unmutated immunoglobulin variable region genes. Response assessment was performed at the end of each cycle, two months after completion of treatment, and each 3–6 months thereafter until the patients experienced disease progression and/or required further treatment. Objective responses were observed in all 14 patients, with 6 patients achieving a complete response (CR) and the remainder a partial response (PR) as per the NCI-working group criteria. We observed a significant decrease in peripheral white blood cell (WBC) counts, increase in hemoglobin, elevation of platelet counts and a dramatic decrease in lymphadenopathy and splenomegaly. Five of the treated patients have not required further treatment with a median follow up of 26 months. Of these 5 patients 3 have maintain a CR. The median time to progression (TTP) was 12 months. Overall, the treatment was well tolerated and all the patients, except one, completed 3 cycles of therapy. The majority of adverse events were Grade I-II (fluid retention, cough, transient hyperglycemia, fatigue). In addition, we observed 7 episodes of grade III-IV toxicity secondary to (anemia, CMV esophagitis and GI bleeding with one case each and two cases each of thrombocytopenia and neutropenia). These data suggest that treatment with the combination of Rituximab® and HDMP has increased activity over treatment with either agent alone and may produce durable complete responses in patients with refractory and / or relapsed CLL.

A phase II evaluation of the combination of paclitaxel protein-bound and carboplatin in the first-line treatment of advanced non-small cell lung cancer (NSCLC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7127-7127 ◽  
Author(s):  
J. P. Allerton ◽  
C. T. Hagenstad ◽  
R. T. Webb ◽  
G. B. Smith ◽  
R. Birch ◽  
...  
Keyword(s):  
Response Rate ◽  
Performance Status ◽  
Metastatic Breast ◽  
Stage Iv ◽  
Complete Response ◽  
Stage Iiib ◽  
Ecog Performance Status ◽  
Kaplan Meier ◽  
Experienced Grade

7127 Background: Abraxane (A) is a cremophor free, albumin-bound nanoparticle of paclitaxel (P) approved for the treatment of metastatic breast cancer. Belani et al. (JCO 21: 2933–2939, 2003) reported that P 100 mg/m2 days 1, 8 and 15 q 28 days with C AUC 6 on day 1 led to a 32% response rate in 132 patients (pts) with NSCLC. The median time to progression (TTP) was 35 weeks (wks) for stage IIIB and 29 wks for stage IV. Methods: This study was designed to determine if substituting A for P at an identical dose would lead to an improved response rate, TTP or decreased toxicity. Results: Fifty-six pts with stage IIIB/IV NSCLC previously untreated with chemotherapy were enrolled. The median age was 66 (range 37 - 83); 37 were male and median ECOG performance status was 1 (range 0–2). Thirteen pts were stage IIIB. Metastases included bone (17), liver (7), brain (2) and lymph nodes (16). Currently a total of 239 cycles of therapy have been administered with a median of 4 (range 1–8) cycles per pt. In 194 (81%) full dose A was administered on days 1, 8 and 15. The table below shows toxicities compared to P: Seven pts (13%) experienced grade (G) 1 neuropathy and 3 pts (5%) experienced G 2 neuropathy. Five pts were inevaluable for response due to removal from study after <2 cycles of treatment (2 died from progressive disease, 2 because of toxicity - thrombocytopenia and neutropenia - and 1 refused). Of 51 evaluable pts 1 (2%) had a complete response and 23 patients (45%) achieved a partial response. Four of 10 evaluable stage IIIB pts obtained a PR. Twenty-one pts were stable for at least 12 weeks of whom twenty remain stable at 12–29 weeks and one progressed at 23 weeks. A total of 13 pts have progressed and 3 pts have died. The Kaplan-Meier estimate of median TTP is 23 wks and maximum follow up is 34 wks. Conclusions: We conclude that combining A and C is tolerable and active in the treatment of newly-diagnosed NSCLC and antitumor activity compares favorably to that of P/C. Further studies are warranted in this population. [Table: see text] [Table: see text]

A phase II study of capecitabine and oxaliplatin (CAPOX) in metastatic adenocarcinoma of the small bowel (SBA) or ampulla of Vater

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14025-14025
Author(s):  
M. J. Overman ◽  
S. Chedid ◽  
J. Morris ◽  
S. Waldrum ◽  
R. A. Wolff
Keyword(s):  
Small Bowel ◽  
Performance Status ◽  
Complete Response ◽  
Ampulla Of Vater ◽  
Ecog Performance Status ◽  
Ampullary Adenocarcinoma ◽  
Highly Active ◽  
Common Grade ◽  
Grade 3 ◽  
Tumor Types

14025 Background: Metastatic SBA and ampullary adenocarcinoma (AAC) are incurable, aggressive malignancies. Limited data exists regarding the role of systemic chemotherapy in these diseases. Given the marked activity of CAPOX in other cancers of the gastrointestinal tract, we have investigated the activity of this combination in these two tumor types. Methods: Patients (pts) with either metastatic or unresectable SBA and AAC who had adequate organ function, ECOG performance status (PS) ≤2 and measurable disease per modified RECIST criteria were enrolled. Prior use of 5-FU or capecitabine as adjuvant therapy, neoadjuvant therapy, or with radiation was allowed. CAPOX was administered as a 21 day cycle with oxaliplatin 130mg/m2 IV on day 1 and capecitabine 750mg/m2 PO BID days 1–14. Up to 30 pts will be enrolled. The primary endpoint is overall response rate (ORR). Results: Eleven pts have been enrolled from 11/04 to 12/05 (6 with AAC and 5 with SBA). Ten pts have received ≥2 cycles and are evaluable for response. All pts had metastatic disease and none had received prior chemotherapy. Patient (pt) characteristics: median age 59 (49–76); M/F (4/7); 91% PS 0–1. Grade 3/4 toxicities included fatigue (5), neuropathy (1), anorexia (1), thrombocytopenia (1), hypokalemia (1), hyponatremia (1), and musculoskeletal (1). Common grade 1/2 toxicities included neuropathy (8), nausea (8), diarrhea (6), and fatigue (5). Four pts required dose reduction and 1 pt discontinued due to toxicity (grade 3 fatigue). Six pts, 3 AAC and 3 SBA, responded with an ORR of 60% (95% CI 31 to 83%). Five responses have been confirmed and 1 AAC pt obtained a complete response after 5 cycles of treatment. Median time to progression was 6.8m (95% CI 4.4 to 9.3+m). Conclusions: The combination of CAPOX is both well-tolerated and highly active. The ORR of 60% is one of the highest yet reported in the literature for the treatment of adenocarcinoma of the small bowel and ampulla of Vater. Enrollment continues on this trial. (Supported by a research grant from Sanofi-Aventis). [Table: see text]

The combination of the HER2 antibody trastuzumab, the EGFR tyrosine kinase inhibitor gefitinib, and docetaxel as first-line therapy in patients with HER2 overexpressing stage IV breast carcinoma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1057-1057
Author(s):  
G. Somlo ◽  
M. Koczywas ◽  
T. Luu ◽  
M. McNamara ◽  
V. Bedell ◽  
...  
Keyword(s):  
Performance Status ◽  
Stage Iv ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Time To Progression ◽  
Ecog Performance Status ◽  
Ventricular Ejection Fraction ◽  
Grade 3 ◽  
Topo Ii ◽  
To Receive

1057 Background: Interference with both HER2 and epidermal growth factor (EGFR) dependent pathways may improve therapeutic efficacy of docetaxel (doc) in pts with HER2 overexpressing (+) BC. Methods: Patients (pts) without prior chemotherapy (Rx) exposure for stage IV HER-2 + BC were enrolled. Prior hormonal or adjuvant Rx inclusive of taxane or trastuzumab (tras) were allowed. A left ventricular ejection fraction of > 45% and ECOG performance status of ≥ 2 were required. Pts were to receive doc 75 m2, tras every 3 weeks, and gefitinib (gef) 250 mg daily. BC samples from 12 pts were analyzed by FISH for HER2 and EGFR amplification (amp), and topoisomerase II (topo II) amp or loss. IHC was to be performed to examine p-Src, p-STAT3, Ki67 and survivin expression. Results: The median age was 49 (range, 34–67) and ECOG performance status 0.5 (0–1). The first 9 patients received gef 250 mg daily; 2 pts received dox 75 mg/m2 and developed grade 3 febrile neutropenia (neu), hence, additional pts received doc at 60 mg/m2: 3 more episodes of grade 3 neu were seen. Gef was held due to grade 3 dermatitis (2 pts) and diarrhea (2 pts). Pts received a median of 6 cycles (3–10). Gef schedule then was changed, and was prescribed on days 2–14, only. Three of the next 9 pts experienced grades 3 or 4 neu, and we observed 3 cases of grade 3 gastrointestinal toxicities; pts were able to receive 11 + (range; 5–25+) cycles on this schedule (p<0.04). There were 4 complete (CR)and 6 partial R (23 % CR, 59 % overall R), and 3 pts had stable disease (SD; all R and SD confirmed); 3 pts progressed at 4, 4, and 5 mos, 1 pt was inevaluable. The median time to progression is 12 + mos. Samples from 3 pts revealed topo II amplification and one pt sample showed loss of one topo II allele; none were amplified for EGFR. Outcome will be correlated with IHC defined signal trasduction status and proliferation rates. Conclusions: The combination of doc, tras, and short course of gef is feasible, with encouraging R and SD rates and time to progression. Further exploration of simultaneous blockage of multiple signal transduction pathways is indicated in combination with chemoRx. Supported by NCI CA33572 and by a grant from AstraZeneca. No significant financial relationships to disclose.

Phase II study with preoperative oxaliplatin (O), cisplatin (P), 5-fluorouracil (F) (OPF) and radiation (XRT) in patients with esophageal (ES), gastroesophageal (GE), and gastric (G) cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15612-e15612
Author(s):  
M. Pera ◽  
R. Gallego ◽  
M. Martin-Richard ◽  
C. Montagut ◽  
M. Iglesias ◽  
...  
Keyword(s):  
Phase Ii ◽  
Median Overall Survival ◽  
Phase Ii Study ◽  
Performance Status ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Surgical Oncology ◽  
Primary Objective ◽  
Ecog Performance Status ◽  
Eligibility Criteria

e15612 Background: A phase I study showed the feasibility of the triplet combination (OPF) with XRT in ES and GE cancer (Maurel et al, IJRBOP, 2005). We conducted a phase II study to evaluate the efficacy of the regimen. Methods: Enrolled pts had resectable, high-risk (HR) based on endoscopic ultrasonography (EUS) (uT3, uN1 or uT4 if deemed resectable) ES, GE and G cancer. The primary objective was to determine the pathologic complete response (pCR). If 2 or more pCR were reported in the first 18 pts treated, enrollment continues with 23 additional pts. Eligibility criteria: squamous cell or adenocarcinoma of the ES, GE or G cancer and ECOG Performance status (PS) 0–1. Staging was done with EUS and computed spiral tomography. Laparoscopic staging was mandatory for pts with ES, GE and G adenocarcinoma. Pts received 2 cycles of O 85 mg/m2, P 55 mg/m2, F (3 g/m2 in 96h CI) q4w, with concomitant 45 Gy XRT in 25 fractions; surgery was planned 5–8 weeks after XRT. All pathological specimens were reviewed by a unique pathologist and regression analysis was recorded using Cologne (C) and M.D.Anderson (MDA) classification for ES and European Journal of Surgical Oncology (EJSO) for GE and G. Results: Between 5/04 to 12/07, 41 pts were enrolled in 5 Spanish Institutions. Median age 62 yrs (39–75 yrs); Male/female 83%/17%; PS 0/1 27%/73%; ES/GE/G 39%/32%/29%; EUS stageT3N0 (20%), T2–3N1 (65%) and T4 (10%). G3/4 adverse events included asthenia (27%), infection (7%), diarrhea (7%) and stomatitis (5%). There were 2 toxic deaths. Of the 31 pts who underwent surgery, there were R0=94%/R1=3%/R2= 3%. 7/41 pts (17%) achieved pCR. Using C and MDA classification, 9/14 (61%) and 12/14 (85%) ES achieved grade IV/III and P0/P1 regression, respectively. With EJSO classification 3/17 (18%) GE and G tumors achieved pCR. Median time to progression or death (PFS) was 16.2 (CI:12.2-NR) months (mo). Median overall survival (OS) was 28.9 mo. (CI: 22.5-NR). Conclusions: Although in the whole group pCR, PFS and OS does not appear superior to results achieved in other trials with preoperative P/F/XRT in HR pts, the OPF regimen seems specially active in ES cancer. No significant financial relationships to disclose.

To analyze efficacy and safety of pegfilgrastim versus filgrastim in patients with breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20587-e20587 ◽  
Author(s):  
C. T. Satheesh ◽  
S. Tejinder ◽  
J. Ankit ◽  
K. V. Sajeevan ◽  
K. C. Lakshmaiah ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Febrile Neutropenia ◽  
Performance Status ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Ecog Performance Status ◽  
Safety And Efficacy ◽  
The Mean ◽  
Support Methods ◽  
To Receive

e20587 Background: We evaluated the safety and efficacy of a single fixed 6 mg dose of pegfilgrastim (a pegylated version of filgrastim) per cycle of chemotherapy, compared with daily administration of filgrastim, in the provision of neutrophil support. Methods: Patients with carcinoma of breast, less than 65 yrs with ECOG performance status 0 or 1 treated at our institution were randomized to receive either a single 6 mg subcutaneous (s.c.) injection of pegfilgrastim or daily 5 mg/kg s.c. injections of filgrastim, after adjuvant or neoadjuvant chemotherapy with doxorubicin, cyclophosphamide and docetaxel (60 mg/m, 600 mg/m2 and 75 mg/m2, respectively)q3 wk. Duration of grade 4 neutropenia (DSN), incidence of febrile neutropenia (FN), grade 4 neutropenia (SN), IV anti-infective use (IV), hospitalization and adverse events like bony pain (BP), anemia & thrombocytopenias were assessed as safety endpoints. Results: 71 patients were analyzed from Aug 2007 to Dec 2008. The median age in pegfilgrastim group is 58 years and filgrastim is 57 years respectively. Results are shown ( Table ). The mean duration of grade 4 neutropenia (DSN) in cycle 1 was 2.0 and 1.7 days for the pegfilgrastim and filgrastim groups, respectively. Results for all efficacy end points in cycles 2–6 were consistent with the results from cycle 1. A trend towards a lower incidence of febrile neutropenia was noted across all cycles with pegfilgrastim compared with filgrastim (10.7% versus 18.6%, respectively). Conclusions: A single fixed dose of pegfilgrastim administered once per cycle of chemotherapy was comparable to multiple daily injections of filgrastim. [Table: see text] No significant financial relationships to disclose.

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