PURPOSE Tracheoesophageal fistulae are rare complications of thoracic cancers and their treatments. Novel antiangiogenic agents in cancer treatment such as bevacizumab potentially impact wound healing and may contribute to tracheoesophageal fistula development. PATIENTS AND METHODS We conducted two independent phase II clinical trials in small-cell lung cancer and non-small-cell lung cancer using bevacizumab in combination with chemotherapy and radiation. Both trials were intended to assess preliminary efficacy and safety outcomes. Results For the limited-stage small-cell lung cancer trial, 29 patients were enrolled beginning April 2006, and closed early due to toxicity in March 2007 (14-month median follow-up). The locally advanced, non-small-cell lung cancer trial opened with enrollment limited to five patients in February 2007, and closed early due to safety in December 2007. In each trial, we observed tracheoesophageal fistulae development and related morbidity and mortality, prompting early trial closures, US Food and Drug Administration warnings, and a change in bevacizumab labeling. CONCLUSION The current data from the final reports from these two trials suggest bevacizumab and chemoradiotherapy are associated with a relatively high incidence of tracheoesophageal fistulae formation in both small-cell lung cancer and non-small-cell lung cancer settings. Strategies to safely incorporate novel antiangiogenic agents into combined-modality therapy in lung cancer are needed.

Primary Purpose. The objective of this retrospective observational cohort study was to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in patients with chemotherapy-induced anemia using data from noncontemporaneous chart audits conducted at a community-based oncology practice.Materials and Methods. For the first chart audit, data were collected from consecutive patients with nonmyeloid malignancies with diagnoses of chemotherapyinduced anemia and hemoglobin levels ≤10.5 g/dl who were receiving concurrent chemotherapy and had at least 5 weeks of visits from July-September 2000. After therapeutic substitution of darbepoetin alfa for epoetin alfa for all patients with chemotherapy-induced anemia, data were collected from consecutive darbepoetin alfatreated patients with diagnoses of chemotherapy-induced anemia and at least 8 weeks of visits from June-October (darbepoetin alfa was approved in July 2002).Results. Most (86%) of the 212 epoetin alfa-treated patients had received an initial dose of 40,000 U once weekly, and most (85%) of the 196 darbepoetin alfatreated patients had received a fixed dose of either 100 µg once weekly (49%) or 200 µg every 2 weeks (36%). At 8 weeks, the mean change in hemoglobin level was 1.1 g/dl for the darbepoetin alfa patient group and 1.0 g/dl for the epoetin alfa patient group.Discussion. Utilization, dose escalation rates, and clinical outcomes were considered comparable for the darbepoetin alfa and epoetin alfa patient groups.Conclusions. Darbepoetin alfa, 100 µg once weekly or 200 µg every 2 weeks, appears to be as effective as epoetin alfa, 40,000 U once weekly, for the treatment of chemotherapy-induced anemia in the clinical practice setting. The Oncologist 2004;9: 451-458

A significant number (some 20%) of patients with thrombotic thrombocytopenic purpura do not respond to standard therapy and die. We reasoned that early identification of those who are likely to fail standard therapy would allow the rational introduction of other treatment modalities. To this end we prospectively evaluated 27 consecutive patients, examining serum LDH levels and platelet counts as markers of disease activity and as predictors of outcome. All patients were treated, according to a written protocol, with high volume plasma exchange (35 ml/kg), prednisone, aspirin, and persantine. Twenty-one of the 27 patients (78%) are alive following therapy. Initial LDH and platelet values did not distinguish between the survivors and nonsurvivors. However, by day 3 of therapy both LDH levels and platelet counts differed significantly between the two groups. Mean day 3 LDH level for survivors was 364 units/L, and for nonsurvivors, 891 units/L (P < 0.005). Mean day 3 platelet count for survivors was 119,000/microL, and for nonsurvivors, 46,000/microL (P < 0.005). Receiver Operator Characteristic curves were constructed and assessed by calculating the area under the curve. This analysis showed that LDH is able to discriminate survivorship one day earlier than platelet count. Both LDH level and platelet count are excellent predictors of survival, under standard therapy, after 3 days of treatment. Early identification of those at greatest risk will facilitate the early institution and evaluation of alternative methods of treatment, such as splenectomy, intravenous Ig, or Vincristine.

This study, in an older, predominantly Medicare Advantage oncology cohort, found differences by SOC in treatment patterns and cost, but not quality. Where differences were found, patients receiving care in the HO had shorter duration of therapy and fewer infusions for specific treatment regimens, but higher healthcare costs than those treated in a PO.

6635 Background: The Oncology Care Model (OCM) is intended to incentivize physicians to improve the quality and reduce the cost of cancer care. In OCM, providers are accountable for all costs during six month episodes of care relative to target costs (TC) derived from a baseline spending period (BSP; 2013-2015). This accountability is intended to foster care coordination to reduce preventable emergency department visits and hospitalizations (EDH). Benefits of reducing EDH may be diluted when new treatment indications for costly immunotherapies (IO) are introduced into clinical practice after BSP. Methods: We identified all non-small cell lung cancer (NSCLC) and bladder cancer (BC) OCM episodes attributed to Tennessee Oncology (TO), a large community oncology network of over 90 oncologists, during performance period 2 (PP2; the most recent PP with available data). We selected NSCLC and BC because both diseases have IO indications that became standard of care after BSP. Using claims data analytics software, we identified all NSCLC and BC episodes with spending above TC, and found a subset of these above target episodes (ATEs) without any EDH that remained above TC due to IO use. Two medical oncologists reviewed these cases in duplicate to assess guideline concordance of IO. Results: During PP2 there were 2,623 OCM episodes attributed to TO, including 240 NSCLC and 31 BC episodes. Spending was above TC in 118 (49%) and 13 (42%) of NSCLC and BC episodes, respectively. For these NSCLC and BC ATEs, EDH was prevented in 62 (53%) and 5 (38%) of cases, respectively. In NSCLC and BC ATEs without EDH, 43 (69%) and 5 (100%) of episodes included IO, respectively. Clinician review in duplicate (S.M.S.; C.A.W.) found that the use of IO was NCCN guideline concordant in 33 (77%) and 4 (80%) of these NSCLC and BC cases, respectively (K = 0.87). Conclusions: Guideline-concordant use of expensive IO as its treatment indications expand poses substantial challenges to meeting cost targets in OCM, even when practices prevent EDH. [Table: see text]

Purpose. Epoetin alfa administered s.c. three times weekly or once weekly increases hemoglobin (Hb) levels, decreases transfusion requirements, and improves quality of life in anemic cancer patients receiving chemotherapy. This study assessed the feasibility of using higher initial doses of once-weekly epoetin alfa followed by less frequent maintenance doses to increase and then maintain adequate Hb levels in this population. Materials and Methods.In this open-label, nonrandomized, pilot study, anemic (baseline Hb ≤11 g/dl) cancer patients undergoing chemotherapy received initial doses of epoetin alfa of 60,000 U s.c. once weekly to increase Hb levels by at least 2 g/dl, followed by 120,000 U s.c. every 3 weeks to maintain Hb levels. The maximum treatment duration was 24 weeks.Results. The mean baseline Hb level was 10.1 ± 0.8 g/dl (n = 20). Once-weekly dosing resulted in mean Hb level increases of 1.0 ± 1.1 g/dl by week 4 and 2.9 ± 1.9 g/dl by week 8; 86% and 79% of patients evaluable at week 8 and week 12, respectively, demonstrated increases of at least 2 g/dl (target Hb level of ≥12 g/dl). Thirteen patients (65%) received at least one maintenance dose; the mean Hb level increased from 12.8 ± 1.1 g/dl before starting maintenance therapy to 13.3 ± 1.4 g/dl at the last maintenance week. Both dosage regimens were well tolerated. TheOncologist ® LEARNING OBJECTIVESAfter completing this course, the reader will be able to:1. List the recommendations in current clinical practice guidelines on epoetin alfa dosing and administration regimens for patients with cancer and chemotherapy-related anemia.2. Discuss the benefits associated with epoetin alfa therapy in cancer patients with anemia receiving chemotherapy, in terms of increased hemoglobin levels, lower transfusion needs, and improved quality of life.3. Explain how higher initial doses of once-weekly epoetin alfa followed by less frequent maintenance dosing with epoetin alfa in anemic cancer patients undergoing chemotherapy may be beneficial, both to the patient and to the health care provider.Access and take the CME test online and receive one hour of AMA PRA category 1 credit at CME.TheOncologist.com CME CME Patton, Kuzur, Liggett et al. 91 Conclusions. Once-weekly epoetin alfa at a dose of 60,000 U effectively increased Hb levels by week 8; 86% of patients achieved rises of at least 2 g/dl or Hb levels ≥12 g/dl. Moreover, epoetin alfa at doses of 120,000 U every 3 weeks maintained or increased Hb levels. Results from this pilot study suggest that higher initial once-weekly dosing of epoetin alfa followed by less frequent maintenance dosing appears to be feasible for treating anemia in cancer patients undergoing chemotherapy. Further evaluation of these and other epoetin alfa dosage regimens is warranted. The Oncologist 2004;9:90-96

7085 Background: Targeting VEGF has proven to be an effective tx strategy in many solid tumors including non-small cell lung cancer. VEGF expression in SCLC provides rationale for studying B in addition to chemoradiotherapy. Methods: The endpoints of this multicenter community-based study were to assess the safety, response rate (RR), and progression-free survival (PFS) of I/C/RT followed by B in patients (pts) with LS-SCLC. Tx included: C AUC = 5 IV D1, I 50mg/m2 IV D1,8 Q 21D x 4 cycles, and RT 1.8 Gy daily to a total of 61.2 Gy, beginning with the 3rd cycle. 3rd and 4th cycles were 28D each. Pts were restaged after 4 cycles. If no progressive disease (PD) pts received B 10 mg/kg IV Q 14D x 10 doses. Eligibility included: measurable disease, ECOG PS 0–1, informed consent, and no new brain metastases or bleeding. Results: Fifty-seven pts were enrolled from 8/03 to 10/04. Forty-five pts (79%) and 41 pts (72%) received planned tx with I/C/RT and B, respectively. The range of follow-up is 14–28 months. Baseline features: median age 65 years (42–80); male/female, 37%/63%; ECOG PS 0,1: 26%/74%. Grade (G) 3/4 non-hematologic toxicity: diarrhea (9%), DVT (4%), vomiting (11%), and fatigue (9%). G3/4 hematologic toxicity: neutropenia (37%), anemia (5%), and thrombocytopenia (13%). Only 9% of pts experienced G3/4 toxicity during B tx (1 pt each: DVT, hypokalemia, depression, pain, and colon perforation). There were 2 tx-related deaths (both from respiratory failure; 1 and 2 doses of B had been administered). Complete/partial responses were observed in 15 pts (26%)/31 pts (54%), respectively, for an overall RR of 80% (95% CI 70%-90%). Four pts had stable disease, and 5% had PD (4 pts were unevaluable.) 1- and 2-year PFS rates were 63% and 54%, respectively. 1- and 2- year overall survival (OS) rates were 71% and 29%, respectively. Median OS was 15 months. Conclusions: The safety, RR, and 1- and 2-year survival results of I/C/RT followed by B compare favorably with standard tx for LS-SCLC; and B may improve PFS. Assessing the role of B as maintenance tx in improving OS in this setting will require randomized trials. [Table: see text]

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