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Table 2 Side effects of the combined radio-chemotherapy with TMZ and PEG-Dox.

From: RNOP-09: Pegylated liposomal doxorubicine and prolonged temozolomide in addition to radiotherapy in newly diagnosed glioblastoma - a phase II study

Treatment related toxicity **

 

Common toxicity criteria (NCI CTC Version 3.0)

 

RNOP-09

Grade 3

RNOP-09

Grade 4*

EORTC/NCI-C

Grade 3+4

 

N (%)

N (%)

N (%)

Gastrointestinal

   

   Vomitus/nausea

4 (6.3)

0 (0.0)

6 (2)

   Stomatitis

2 (3.2)

0 (0.0)

not reported

   Gastritis

2 (3.2)

0 (0.0)

not reported

   Diarrhea

3 (4.8)

0 (0.0)

not reported

Skin

   

   PPED/rash

4 (6.3)

0 (0.0)

9 (3)

   Herpes simplex infection

2 (3.2)

0 (0.0)

not reported

   Edema

2 (3.2)

0 (0.0)

not reported

   Anaphylaxis

0 (0.0)

1 (1.5)

not reported

Infection

   

   Pneumonia

8 (12.7)

1 (1.5)

not reported

   Wound infection

1 (1.5)

0 (0.0)

not reported

   not specified

9 (14.2)

0 (0.0)

20 (7)

Blood/bone marrow

   

   Leukopenia

9 (14.3)

3 (4.7)

20 (7.0)

   Lymphopenia

6 (9.5)

27 (43.9)

not reported

   Thrombopenia

4 (6.3)

3 (4.7)

33 (12.0)

   Anemia

0 (0.0)

2 (3.2)

4 (1.0)

Cardiac and vascular toxicity

   

   Cardiac toxicity

0 (0.0)

0 (0.0)

not reported

   Deep vein thrombosis

2 (3.2)

0 (0.0)

not reported

   Pulmonary embolism

0 (0.0)

1 (1.5)

not reported

  1. * Two additional patients died, one due to pulmonary embolism and une due to unclear decline in general condition (CTC grade 5).
  2. ** Side effects are listed irrespective if they were related to the therapy.