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Study Purpose

To evaluate the effectiveness of dexamethasone and pyridoxine on the frequency and severity of palmar-plantar erythrodysesthesia (PPE) in patients with solid tumors receiving pegylated liposomal doxorubicin (PLD).

Intervention Characteristics/Basic Study Process

Evaluable patients had at least two cycles of therapy. A total of 51 cycles of PLD was applied to the 19 patients. The maximum tolerated dose was 60 mg/m2 every 28 days. In a second step, interval reductions at the highest four weekly doses from 28 to 21 to 14 days were planned. Patients received oral dexamethasone 8 mg BID on days 1 to 5 with vitamin B6 100 mg BID continuously along with PLD.

Sample Characteristics

  • The study reported on a sample of 19 patients who had solid tumors and were receiving PLD.
  • PLD doses ranged from 40 to 60 mg/m2.

Setting

  • Department of Medicine at the University of Tuebingen Medical Center in Germany
  • Department of Medicine at the University of Essen Medical Center in Germany

Measurement Instruments/Methods

PPE was evaluated with a scale from grade 1 to 4. The specific grading scale was not discussed.

Results

  • Three of seven patients with 21-day PLD intervals developed grade 3 or 4 PPE.
  • At the 28-day PLD interval, grade 3 PPE occurred in only in 1 of 12 patients who were receiving 60 mg/m2 PLD during the third cycle. That patient discontinued dexamethasone on day 2.

Conclusions

Compared to reported frequencies of up to 25%, the incidence of PPE caused by PLD appeared to decrease with concomitant dexamethasone and vitamin B6.

Limitations

  • The sample size was small.
  • This was not a randomized clinical trial, and no control or comparison group was used.
  • The description of the measurement tool or method used to grade PPE symptoms was inadequate, and reliability and validity were unclear.