ASCO 05: Conference Recaps

Topic: Breast Cancer

Capecitabine as Single Agent in Elderly Patients With Metastatic Breast Cancer (MBC)

Link Code: o6415

Authors: Zamora P, álvarez de Mon M, Calvo L, et al.

Abstract Number: 843

Recap: This study was conducted to determine whether response rate to capecitabine is similar in elderly patients with MBC and to evaluate its toxicity profile. Of the 10 patients with a median age of 77 years, two achieved partial response, three exhibited stable disease, and five progressed, resulting in an objective response rate of 20%. At follow up, the median TTP was 7.4 months and the median overall survival was 11.8 months. Capecitabine taken twice daily orally by elderly patients “seems to be an effective and well tolerated treatment in patients with MBC.”

Presentation Available: No

Combination Chemotherapy With Docetaxel and Gemcitabine in Anthracycline Pretreated Patients With Metastatic Breast Cancer (MBC)

Link Code: o6416

Authors: Slee PH, Jong PC, Jong RS, et al.

Abstract Number: 728

Recap: This study assessed the efficacy and safety of combination treatment with docetaxel and gemcitabine in patients with anthracycline pretreated MBC. Of the 38 patients who were evaluable for response and toxicity, 23 experienced partial responses, yielding an overall response rate of 60%. The combination chemotherapy with gemcitabine and docetaxel proved “feasible in anthracycline pretreated MBC” and demonstrated “promising efficacy.”

Presentation Available: No

Dietary Fat Reduction in Postmenopausal Women With Primary Breast cancer: Phase III Women’s Intervention Nutrition Study (WINS)

Link Code: o6417

Authors: Chlebowski RT, Blackburn GL, Elashoff RE, et al.

Abstract Number: 10

Recap: A cohort of 2,437 women age 48-79 with early stage resected breast cancer were randomized within a year following surgery to dietary intervention or control groups. All subjects were administered “standard breast cancer management,” including mastectomy or lumpectomy plus radiation and tamoxifen, and those in the dietary intervention group underwent eight bi-weekly counseling sessions performed by nutritionists. Recurrence risk factors were similar between the two groups, while dietary fat intake reduction was found to be greater in the dietary group.

Presentation Available: Yes (Audio/Slides)

Paclitaxel and Epirubicin Versus 5-fluorouracil, Epirubicin and Cyclophosphamide in Preoperative Chemotherapy of Stage III A and III B of Chemotherapy-Naïve Breast Cancer: Comparative Analysis of Response Rate

Link Code: o6418

Authors: Badulescu A, Badulescu F, Schenker M, and Badea P

Abstract Number: 772

Recap: Dr. Badulescu and colleagues compared the efficacy of epirubicin followed by paclitaxel (PE) to 5-fluorouracil followed by epirubicin and cyclophosphamide, administrated preoperative in stages III A or III B BC. Subjects in the PE regiment yielded a higher response rate with the same toxicity, leading investigators to recommend it “as a treatment of choice for preoperative chemotherapy of stage III A and III B BC.”

Presentation Available: No

Presence of Circulating Tumor Cells (CTC) in Metastatic Breast Cancer (MBC) Predicts Rapid Progression and Poor Prognosis

Link Code: o6419

Authors: Cristofanilli M, Budd GT, Ellis MJ, et al.

Abstract Number: 524

Recap: Having previously reported association between the presence of five or more circulating tumor cells (CTCs) in 7.5 mL of blood from women with MBC and poor survival, Dr. Massimo Cristofanilli and team included data of CTCs at different time points after initiation of therapy in this study. In multivariate analyses, CTC remained the strongest and most significant independent predictor of poor outcome. Different therapeutic approaches should be considered for these two subsets of patients, according to the researchers.

Presentation Available: Yes (Audio/Slides)

“A lifestyle intervention resulting in dietary fat reduction may increase relapse-free survival in a population of mostly postmenopausal breast cancer patients.”

—Rowan T. Chlebowski, MD, PhD

Topic: Colorectal/Gastrointestinal Cancer

Dose Reduced First-Line Capecitabine (Xeloda) Monotherapy in Older and Less Fit Patients With Advanced Colorectal Cancer (ACRC)

Link Code: o64118

Authors: Cripps MC, Vincent M, Jonker D, et al.

Abstract Number: 3577

Recap: At a median 7.2 months of follow-up for this multicenter phase I/II trial of 214 patients—of whom 167 were age 65 years or older, 139 had ECOG performance status of 1 or greater, 105 had elevated LDH, 54 had prior pelvic radiation, and 5 had liver enzyme abnormalities—131 patients were alive following a median 4 and mean 6/5 cycles of capecitabine 2000mg/m2 d1-14 q21d. Cripps, et al. concluded that lower dose “capecitabine is tolerable and active in less fit patients.”

Presentation Available: Yes (Slides)

Erbitux (Cetuximab) Plus FOLFOX for Colorectal Cancer (EXPLORE): Preliminary Efficacy Analysis of a Randomized Phase III Trial

Link Code: o64119

Authors: Jennis A, Polikoff J, Mitchell E, et al.

Abstract Number: 3574

Recap: Designed for patients with metastatic, EGFR-positive colorectal cancer who took irinotecan as first-line therapy, this randomized phase III study compared cetuximab plus FOLFOX4 to FOLFOX4 alone. Of those who received cetuximab 400 mg/m2 initial dose followed by 250 mg/m2 weekly dose and FOLFOX4 d1,d2 q 2 weeks, nine had partial response (PR), 20 had stable disease (SD), and six had progressive disease (PD); four patients had PRs, 26 had SDs, and nine had PS in the arm that received FOLFOX4 q 2 weeks. It was concluded that, in patients with metastatic colorectal cancer who were treated with irinotecan, combination FOLFOX4 and cetuximab is active.

Presentation Available: Yes (Slides)

Perioperative Chemotherapy in Operable Gastric and Lower Oesophageal Cancer: Final Results of a Randomised, Controlled Trial (the MAGIC trial, ISRCTN 93793971)

Link Code: o64120

Authors: Cunningham D, Allum WH, Stenning SP, and Weeden S, for the NCRI Upper GI Cancer Clinical Studies Group

Abstract Number: 4001

Recap: In an effort to determine whether the significant benefit seen with epirubicin, cisplatin, and infused 5-FU in advanced esophageal cancer “translates into a survival advantage in operable disease,” this study randomized 503 patients with operable adenocarcinoma of the stomach, esophagogastric junction, or lower esophagus to perioperative chemotherapy (CSC) or surgery alone (S). With 90% of patients followed to death or more than two years, 319 deaths were recorded, with five-year survival rates of 36% and 23% for CSC and S, respectively. Perioperative chemotherapy was determined to significantly improve respectability and progression-free and overall survival in the study population.

Presentation Available: Yes (Audio/Slides)

Randomized Phase III Trial Comparing Infused Irinotecan/5-fluorouracil (5-FU)/Folinic Acid (IF) Versus 5-FU/FA (F) in Stage III Colon Cancer Patients (PETACC 3)

Link Code: o64122

Authors: Van Cutsem E, Labianca R, Hossfeld D, et al.

Abstract Number: LBA8

Recap: PETACC-3 is a trial of adjuvant chemotherapy with infused irinotecan/5-FU/FA (IF) versus 5-FU/FA (F; LV5FU2 regimen), which aims to “show the increased activity of IF in patients with stage III colon cancer.” Hazard ratios for disease- and relapse-free survival were 0.89 and 0.87, respectively, in stage III patients. Both 60-day mortality and mortality within 30 days of the last treatment were low. In the study, irinotecan significantly increased the efficacy of LV5FU2 in a pooled population of stage II and stage III patients.

Presentation Available: Yes (Slides/Audio)

“The current AJCC staging classification for esophageal cancer does not accurately reflect pathologic predictors of survival after pre-operative chemoradiotherapy.”

—Nabil P Rizk, MD

Topic: Multiple Myeloma

Bortezomib Appears to Overcome Poor Prognosis Conferred by Chromosome 13 Deletion in Phase 2 and 3 Trials

Link Code: o64110

Authors: Jagannath S, Richardson PG, Sonneveld P, et al.

Abstract Number: 6501

Recap: Deletion of chromosome 13 [del(13)] by conventional cytogenetics is a key adverse prognostic factor for survival in multiple myeloma (MM) patients (pts); however, data from SUMMIT, a phase II trial with bortezomib, demonstrated that del(13) did not adversely affect survival or response rates. The authors of this presentation analyzed “the prognostic value of del(13) in both the conventional treatment arm (dexamethasone; dex) and the bortezomib arm” using results from the APEX trial, a phase III trial comparing bortezomib and high-dose dex in 669 pts with relapsed MM. Researchers found a significant decrease in survival in 21 pts with del(13) compared with 41 pts without the deletion and determined that “detection of del(13) was associated with markedly decreased survival in the dex arm,” while in the bortezomib arm, del(13) was not linked with a difference in survival. Thus, bortezomib therapy “appears to overcome the adverse impact of del(13) on survival or response rate consistent with findings in SUMMIT.”

Presentation Available: Yes (Audio/Slides)

Changing Trend in Multiple Myeloma Therapy

Link Code: o64111

Authors: Jajeh A, Osafo D, Tamkus D, and Yim B

Abstract Number: 6745

Recap: Dr. Jajeh and colleagues performed retrospective analysis of patients diagnosed with multiple myeloma (MM) during the last two years and identified a “clear shift” in the trend of selecting therapy in patients with MM. The response rate was 65% for patients who were administered thalidomide therapy; 70% of patients were alive with a good response; and 83% of patients who received combination treatment with doxorubicin HCI, vincristine, and four days of pulse dexamethazone achieved complete response and partial response. Of those monitored, more than 65% of patients were African American, 20% were Hispanic, 10% were white, and 5% were of other origins. “Thalidomide,” according to researchers, “has shown superior results considering the high risk presentation and minority status of our patients’ population.

Presentation Available: No

Circulating Plasma Cells Detected by Flow Cytometry as a Predictor of Survival in Patients With Newly Diagnosed Multiple Myeloma

Link Code: o64112

Authors: Nowakowski GS, Witzig TE, Dingli D, et al.

Abstract Number: 6580

Recap: The detection of circulating plasma cells in patients with multiple myeloma is “complex and not readily available in most clinical laboratories.” To explore this, Dr. Nowakowski and colleagues “investigated the prognostic significance of circulating PC detected by flow cytometry (FC)” in a cohort of 303 patients with newly diagnosed multiple myeloma over a period of five years. In 80 patients, no circulating plasma cells were seen; 163 had 0-5; 104 had 6-10; and 36 expressed more than 10 circulating PC. The median overall survival (OS) for the whole cohort was 46 months, while patients with five or less circulating plasma cells had median OS of 59 months and patients with more than five circulating plasma cells had a median OS of 40 months. Researchers found that, in “patients with ISS 2 or 3, the median survival was 26 mo if there were > 5 circulating PC,” and “median survival was 48 mo if the circulating PC number was ≤ 5.” It was concluded that “the number of circulating PC measured by flow cytometry in patients with newly diagnosed MM is an independent predictor of survival.

Presentation Available: No

“In the last five years, we’ve had an astonishing number of new drugs that are active in myeloma, and amazing new insights into the biology of the disease. The impact of these recent advances on the survival of myeloma patients is still to be determined. However, at last we dare to hope that a cure may be within reach.”—Seema Singhal, MD

Topic: Pancreatic Cancer

Analysis of Pancreatic Tumor Types in Familial Pancreatic Cancer

Link Code: o64114

Authors: Wong RF, Omer EN, Kerber RA, Boucher K, Disario JA

Abstract Number: 88

Recap: While a positive family history of pancreatic cancer is a well-defined risk factor for adenocarcinomas, its link to the development of other types of pancreatic neoplasms is unknown. Dr. Robert F. Wong and colleagues used the Utah Population Database (UPDB) to assess the frequency of other malignant pancreatic tumors in patients with familial PC. Predictably, Dr. Wong’s team found that the majority of malignant tumors were adenocarcinomas; however, several other malignancies also occured, according to the researchers. Malignant neuroendocrine tumors were another tumor type that accounted for a relatively high frequency of cases. Further analysis disclosed that in nine families (19%), another tumor type besides ductal adenocarcinoma occurred in at least one member. These findings indicate that individuals with a familial link to pancreatic cancer are at higher risk for the development of other tumor types; further research will hopefully elucidate the risk of developing each pancreatic tumor type compared to the general population.

Presentation Available: Yes (Slides)

Erlotinib Plus Gemcitabine Compared to Gemcitabine Alone in Patients With Advanced Pancreatic Cancer. A Phase III Trial of the National Cancer Institute of Canada Clinical Trials Group [NCIC-CTG]

Link Code: o64115

Authors: Moore MJ, Goldstein D, Hamm J, et al.

Abstract Number: 1

Recap: Since pancreatic cancer is known to frequently over express epidermal growth factor receptor (EGFR), Dr. Malcolm Moore and colleagues assessed the efficacy of adding erlotinib—an oral reversible inhibitor of EGFR tyrosine kinase—to gemcitabine therapy in patients with advanced pancreatic cancer. They studied patients with advanced pancreatic adenocarcinoma who had no prior systemic chemotherapy other than that given concurrently with radiation therapy. Subjects were randomized to receive gemcitabine 1000 mg/m2 plus either erlotinib 100 mg daily or a placebo in a double-blind fashion. Every eight weeks, the researchers evaluated the disease using cross sectional imaging. A difference in overall survival favored the erlotinib arm; the corresponding one-year survival rates were 24% versus 17%. Progression-free survival was also significantly improved in the gemcitabine plus erlotinib treatment group. The researchers concluded that the “addition of erlotinib to gemcitabine significantly improves survival and progression free survival in advanced pancreatic cancer.”

Presentation Available: Yes (Audio/Slides)

A Randomised, Prospective, Multicenter, Phase III Trial of Adjuvant Chemotherapy With Gemcitabine Vs. Observation in Patients With Resected Pancreatic Cancer

Link Code: o64116

Authors: Neuhaus P, Oettle H, Post S, et al.

Abstract Number: LBA4013

Recap: Peter Neuhaus, MD, PhD, and colleagues designed this study to evaluate the efficacy and toxicity of adjuvant gemcitabine in patients with resectable pancreas cancer. Within six weeks after surgery, patients were randomized to receive gemcitabine or observation. Patients in the observation arm received no specific postoperative treatment but were followed similar to the gemcitabine group. The team’s analysis shows a difference in median disease-free survival; the disease-free survival rates were 14.2 months and 7.5 months for the gemcitabine and observation groups, respectively. Subgroup analysis demonstrated increased disease-free survival in patients with or without microscopic resection margin involvement and in those with or without positive lymph nodes. Grade 3/4 toxicities included leucocytes, platelets, diarrhea, and nausea.

Presentation Available: Yes (Audio/Slides)

“Pancreatic cancer is an enigmatic disease about which we have precious little information. If we are to do something about this disease, we really have to understand its genetics and biology.”—Ronald A. DePinho, MD, of Harvard Medical School

Topic: Supportive Care

Aprepitant as Salvage Therapy in Patients With Chemotherapy-Induced Nausea and Emesis Refractory to Prophylaxis With 5-HT3-Antagonists and Dexamethasone

Link Code: o64131

Authors: Bokemeyer C, Oechsle K, Meuller MR, et al.

Abstract Number: 8166

Recap: Bokemeyer, et al presented results of a study that evaluated the efficacy of adding aprepitant—shown to prevent acute and delayed emesis in patients on cisplatin-based chemotherapy—to the treatment of patients who were refractory to prophylaxis with 5-HT3-antagonists and dexamethasone. All patients given aprepitant reported significant subjective improvements and, on a visual analogue scale of 0 to 100 considered their nausea to be below 30°. Further, those with nausea for more than four days and emesis for more than two days decreased from 77% to 12% and from 85% to 0%, respectively.

Presentation Available: No

Final Results of a Randomized, Double-Blind, Active-Controlled Trial of Darbepoetin alfa Administered Once Every 3 Weeks for the Treatment of Anemia in Patients Receiving Multicycle Chemotherapy

Link Code: o64133

Authors: Canon J, Vansteenkiste J, Bodoky G, et al.

Abstract Number: LBA8284

Recap: This phase III trial evaluated and compared darbepoetin alfa administered every three weeks (Q3W) to every week (QW) for a total of 15 weeks using a non-inferiority approach in patients who were anemic, had nonmyeloid malignancy, and were scheduled for 12 or more weeks of chemotherapy. For the Q3W group, transfusion incidence was 19%, compared to 28% for the QW group. Darbepoetin alfa administered once every three weeks was well tolerated and resulted in no differences in toxicities or thrombotic events between the two groups.

Presentation Available: No

Randomized Phase III Study Comparing Standard TIW and Weekly Dosage of Epoetin Alfa With 2 Weeks Loading Dose: Preliminary Results

Link Code: o64134

Authors: Cortesi E, Ricci G, Ucci G, et al.

Abstract Number: 8215

Recap: The standard treatment for anemia in patients with cancer in Europe (10.000 IU TIW) was compared to a loading dose of 40.000 IU twice weekly for the first two weeks followed by 40.000 IU QW until chemotherapy treatment end. In 64 patients for whom data are available, baseline Hb levels were similar for both groups. After two weeks, Hb level rose 0.48 g/dl in the 10.000 IU arm and 0.82 g/dl in the loading arm. Dr. Cortesi and co-researchers concluded that after the two weeks of treatment, “4 doses of epoetin alfa 40.000 IU allow a quicker and sustained response with respect to standard dosage.

Presentation Available: No

Tolerability of Dronabinol Alone, Ondansetron Alone and the Combination of Dronabinol Plus Ondansetron in Delayed Chemotherapy-Induced Nausea and Vomiting

Link Code: o64135

Authors: Jhangiani H, Meiri E, Vredenburgh J, et al.

Abstract Number: 8196

Recap: In this double-blind, placebo-controlled, flexible-dose study, patients with delayed chemotherapy-induced nausea and vomiting and receiving moderate to high emoetogenic chemotherapy all received dexamethasone 20mg and ondansetron 16mg before chemotherapy. Those in the dronabinol, ondansetron, and combination groups were also given dronabinol 2.5mg before and after chemotherapy (day 1), while those in the placebo group did not. Few terminations due to adverse events occurred with the well-tolerated dronabinol. “The low rate of CNS-related adverse events following D treatment may make it a suitable alternative to serotonin antagonist therapy for delayed CINV,” concluded Jhangiani, et al.

Presentation Available: No

“Overall, methylnaltrexone does seem to relieve the suffering from opioid-induced constipation in a very sick, end-of-life population.”—Jay Thomas, MD, PhD

Topic: Lung Cancer

Correlation of Molecular Markers Including Mutations With Clinical Outcomes in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Treated With Gefitinib, Chemotherapy or Chemotherapy and Gefitinib in IDEAL and INTACT Clinical Trials

Link Code: o64125

Authors: Lynch TJ, Bell D, Haber D, et al.

Abstract Number: 7006

Recap: Lynch, et al. took tumor samples from patients enrolled in the IDEAL studies—in which major response and symptom improvements were seen with gefitinib—and the INTACT studies—in which gefitinib showed no therapeutic gain when compared to chemotherapy alone—and sequenced exons 18-21 of the EGFR-TK domain. Of 78 IDEAL study samples that were fully evaluable and validated for exons 18-21, 14 mutations were detected from patients who had adenocarcinoma (12), were females (8), smoked or formerly smoked (9), and had objective responses (6). Of 32 patients with mutations detected from the INTACT studies, 25 had adenocarcinoma, 17 were men, nine never smoked, and 15/23 had objective responses to treatment.

Presentation Available: Yes (Audio/Slides)

ERCC1 mRNA-Based Randomized Phase III Trial of Docetaxel Doublets With Cisplatin or Gemcitabine in Stage IV Non-Small Cell Lung Cancer (NSCLC) Patients

Link Code: o64126

Authors: Rosell R, Cobo M, Isla D, et al.

Abstract Number: 7002

Recap: With the hypothesis that patients “with high tumor ERCC1 levels would have a significantly better response with a” non-cisplation treatment combination, Rosell and colleagues randomized patients with stage IV NSCLC and available tumor biopsy samples to either a control arm (A) that received docetaxel/cisplatin, or a genotypic arm (B) that received either docetaxel/cisplatin (B1) if their ERCC1 levels were low or docetaxel/gemcitabine (B2) if their ERCC1 levels were high. Of 192 patients, those in arm B1 had better response than arms A and B2. “Lower ERCC1 mRNA levels confer better response to [docetaxel/cisplatin], while there is a tendency for [patients] with higher levels to respond better to [docetaxel/gemcitabine] than those with lower levels,” concluded the researchers.

Presentation Available: Yes (Audio/Slides)

Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC): A Phase II Clinical Trial

Link Code: o64128

Authors: West H, Belt RJ, Wakelee HA, et al.

Abstract Number: 7117

Recap: With well-demonstrated, single-agent activity in patients with locally advanced or metastatic NSCLC, pemetrexed and gemcitabine were tested as combination treatment in patients with stage IIIB-IV NSCLC, of whom results of 47 are available. With no negative impact seen on therapeutic index when administering pemetrexed on day eight as opposed to day one, the combination of pemetrexed and gemcitabine showed a disease control rate of 79.4% front-line treatment, “suggesting that this is an active doublet,” concluded West, et al.

Presentation Available: Yes (Slides)

A Phase II Study of Pemetrexed and Carboplatin as Front-Line Chemotherapy in Patients With Malignant Pleural Mesothelioma (MPM)

Link Code: o64129

Authors: Ceresoli GL, Zucali PA, Favaretto A, et al.

Abstract Number: 7172

Recap: With a phase I trial demonstrating that combination pemetrexed and carboplatin was active and well tolerated in malignant pleural mesothelioma, this study aimed to “explore this combination in a phase II setting.” With a median time to progression of six months and a median follow-up of 5.2 months, 25 patients died and 53 remain alive. Thus, the “encouraging activity” of combination pemetrexed and carboplatin in malignant pleural mesothelioma was confirmed, with an excellent toxicity profile.

Presentation Available: Yes (Slides)

“In the last two decades, there has been no significant improvement in overall survival with multiple chemotherapy strategies in extensive stage small cell lung cancer.”—Nasser H. Hanna, MD