Article Figures & Data
Figures
- Figure 1.
The design of the GEM/DOX phase II clinical trial. This phase II, single-center, open-label study enrolled patients with recurrent or metastatic HNSCC who had received prior cisplatin or carboplatin therapy.
- Figure 2.
Kaplan–Meier curves for OS and PFS. Patient response to therapy was assessed by CT scans at every 2 cycles (6 weeks). Response and progression was evaluated using the new international criteria proposed by the RECIST 1.0. Measurable disease is defined as having at least tumor with a diameter of 20 mm or more measured with conventional techniques (CT, MRI, and X-ray) or as a tumor with a diameter of 10 mm or more as measured with a spiral CT scan. OS and PFS were analyzed using Kaplan–Meier curves.
- Figure 3.
Analyses of serum sphingolipids in HNSCC patients during GEM/DOX treatment using LC/MS. A, baseline serum measurements of total ceramide, C18-ceramide, S1P, C16-ceramide, reported as pmol/100 mL of serum. B, changes in sphingolipids, presented as % change between baseline and cycle 3 of treatment (P values were calculated for CR, PR, SD vs. PD).
- Figure 4.
Changes in ceramide and S1P in patients with CR, PR, or SD who have repeated measurements beyond cycle 3. The full spectrum of serum ceramide levels in patients with CR, PR, and SD was measured at every 2 cycles of GEM/DOX treatment until the therapy was terminated using liquid chromatography/tandem mass chromatography.
Tables
- Table 1.
Patient characteristics
Characteristics No. % Age, y Median 56.5 Range 45–77 Initial tumor Oropharynx 8 44.4 Larynx 6 33.3 Hypopharynx 1 5.6 Oral cavity 2 11.1 Multi 1 5.6 ECOG performance status 0 3 16.7 1 12 66.7 2 3 16.7 No. of cycles received 1 2 11.1 2 8 44.4 3 0 0.0 4 4 22.2 5 0 0.0 6 2 11.1 7 0 0.0 8 1 5.6 9+ 1 5.6 Overall response rate (n = 17) CR + PR 4 26a SD 8 47 PD 5 29 -
aEstimated response rate is adjusted for Simon 2-stage design which proceeds to stage II if there is sufficient activity in stage I. Sample size is 18 for all variables, except response rate because of inevaluability of 1 patient.
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- Table 2.
Toxicities
Adverse event Grade 3 % Grade 4 % Constitutional Fatigue 1 5.6 0 0.0 Hematologic Neutropenia 4 22.2 5 27.8 Leukopenia 3 16.7 3 16.7 Anemia 1 5.6 0 0 Thrombocytopenia 1 5.6 2 11.1 Nonhematologic Cough 1 5.6 0 0 Hypocalcemia 1 5.6 0 0 Hypophosphatemia 1 5.6 0 0 Hyponatremia 2 11.1 0 0 Hypokalemia 1 5.6 0 0 Nausea 1 5.6 0 0 Vomiting 1 5.6 0 0 Infection 2 11.1 0 0 DVT 1 5.6 0 0 Dysphagia 1 5.6 0 0 NOTE. Of note, 8/18 patients (44.4%) did not experience significant (>grade 2) toxicity. Patients were assessed on day 1 of every 21-day cycle for changes in performance status and the presence of toxicities. Toxicities were graded according to CTCAE Version 3.0.
Volume 17, Issue 18
