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Table 3 Studies on small molecules.

From: Radiotherapy and "new" drugs-new side effects?

Substance

Author(s)

Year

Study type

N

tumour

RT dose/ChTx/technique

Toxicity

Sunitinib

Chi et al. [153]

2010

Phase II

23

HCC

52.5 (15 Fx) IMRT/3D-CT

9% grade III upper GI bleeding, 4% hepatitis grade III/4% grade III pancreatitis, 26% grade III + IV thrombopenia, 4% grade III leukopenia

 

Stähler et al. [154]

2010

Prospective, non-randomized

22

RCC (all sites)

Median 40 Gy (median 8 Fx)

5% grade IV hypertension, 14% grade III + IV nausea

 

Kao et al. [80]

2009

Phase I

21

Oligometastases

40-50 Gy (10 Fx)

62% grade III + IV lymphopenia, 19% grade III neutropenia, 14% grade III + IV thrombopenia, 5% grade III rectal bleeding

 

Hui et al. [155]

2010

Phase II

13

Nasopharyngeal carcinoma

Sunitinib after RT (60-70 Gy) and multiple Chx

15% fatal hemorrhages, 31% Grade IV hemorrhages, (among other toxicities)

sorafenib

Peters et al. [77]

2008

Case study

1

RCC

8 Gy single dose

Grade V bowel perforation (stopped two days before, three days later recommenced)

lapatinib

Harrington et al. [156]

2009

Phase I

31

LA-HNSCC

66-70 Gy + CisPt

35% grade III mucositis, 19% grade III dermatitis, 13% grade III + IV lymphopenia, 6% grade III neutropenia

gefitinib

Cohen et al. [157]

2010

Phase I

69

LA-HNSCC

IC Carbo/Tax, hydroxyurea + 5-FU, 2 × 1.5 Gy/d

29% grade III + IV neutropenia, 86% grade III + IV mucositis, 33% grade III + IV dermatitis, 3% grade V infections, 17% grade III + IV infections, 4% grade III rash, 3% grade III neurotoxicity

 

Pollack et al. [158]

2011

Phase II

43

Brainstem glioma in children

55,8 Gy

Grade III+IV: lymphopenia (21%), neutropenia (2%), GI (12%), infection (7%), n, pulmonary (5%), renal, skin (2%), metabolic (2%), intratumoral hemorrhage: 7%.

 

Valentini et al. [159]

2008

Phase I/II

41

Rectal cancer

45 Gy + 5.4 Gy + 5-FU

20% grade III + IV GI toxicity, 15% grade III + IV skin toxicity, 39% grade III + IV hepatic toxicity, 10% grade III + IV GU toxicity, 7% other toxicities grade III + IV

 

Wang et al. [160]

2011

Prospective

26

Stage III/IV NSCLC

Median 70 Gy

Grade IV leukopenia 4%, grade IV thrombopenia 8%, grade III esophagitis 4%, grade III pneumonitis 4%

 

Zhang et al. [161]

2009

Phase I

24

NSCLC

54-60 Gy

4% grade III nausea

 

Chen et al. [162]

2007

Phase I

23

HNSCC

Up to 72 Gy

13% grade III dermatitis, 57% grade III + IV mucositis, 39% grade III + IV dysphagia, 17% grade III + IV diarrhea, 30% grade III + IV neutropenia, 9% grade III + IV anemia, 4% grade IV tumour hemorrhage, 4% grade III GI bleeding

 

Maurel et al. [163]

2006

Phase I

18

Pancreatic cancer

45 Gy

No DLT, 11% grade III + IV neutropenia, 6% anemia grade III

 

Czito et al. [164]

2006

Phase I

16

Pancreatic + rectal cancer

50.4 Gy (1.8 Gy) + capecitabine

31% grade III + IV diarrhea

 

Center et al. [165]

2010

Phase I

16

NSCLC

70 Gy 3D-CT + docetaxel

27% grade III + IV hematotoxicity, 27% grade III + IV esophagitis, 20% grade III + IV pulmonary toxicity

 

Schwer et al. [166]

2008

Phase I

15

Malignant glioma

SRS 18-36 Gy

No DLT, no grade > II

 

Olsen et al. [167]

2009

Phase I

12

Pancreatic cancer

50.4 Gy (1.8 Gy)

45% grade III nausea

erlotinib

Brown et al. [168]

2008

Phase I/II

79

GBM

60 Gy + TMZ

18% grade III/IV rash, 16% grade III/IV fatigue, 24% grade III/IV thrombopenia, 4% grade III nausea, 8% grade III diarrhea, 28% grade III/IV leukopenia, 3% grade III anorexia, 18% grade III/IV neutropenia, 6% grade III anemia, 14% grade III lymphopenia, 1% grade V infection without neutropenia, 5% grade III infection without neutropenia, 6% grade III/IV dyspnea, 1% grade III/IV keratitis, 1% grade V pneumonitis, 6% grade III/IV pneumonitis

 

Prados et al. [169]

2009

Phase II

65

GBM

59.4 Gy/60 Gy + TMZ

43% grade III lymphopenia, 3% grade IV neutropenia, 2% grade IV thrombopenia, 8% grade III/IV fatigue, 2% grade III diarrhea, 6% grade III rash

 

Herchenhorn et al. [170]

2010

Phase I/II

37

LA-HNSCC

70 Gy + Cis

No DLT

 

Choong et al. [171]

2008

Phase I

34

NSCLC Stage III

66 Gy (2 Gy), Arm A: Erlotinib + Cis/Eto, Arm B: Induction Carbo/Tax, Carbo/Tax + Erlotinib

41% grade III + IV WBC, 32% grade III + IV neutropenia, 21% grade III + IV thrombopenia, 26% grade III + IV esophagitis, 3% grade III + IV vomiting, 6% grade III + IV diarrhea, 3% grade III/IV pneumonitis/ototoxicity

 

Peereboom et al. [172]

2010

Phase II

27

GBM

60 Gy + TMZ

7% grade V febrile neutropenia, 4% grade V sepsis without neutropenia, 4% grade V PCP, a pt grade III neutropenia, 15% grade III neutropenia, 30% grade III + IV thrombopenia, 56% pts grade III lymphopenia, 15% grade III + IV anemia, 7% grade III fatigue

 

Chang et al. [173]

2011

Retrospective

25

NSCLC

40-50 Gy

4% grade III rash, 4% grade III diarrhea/esophagitis/anemia, 8% grade III neutropenia/thrombopenia, 8% grade V pneumonitis, 4% grade III pneumonitis

 

Li et al. [174]

2010

Phase II

24

LA esophageal cancer

60 Gy + Carbo/Tax

17% ≥ grade III leukopenia, 8% thrombopenia ≥ grade III

 

Broniscer et al. [175]

2009

Phase I

23

GBM

54-59.4 Gy

39% grade III + IV lymphopenia, 4% grade III rash, 4% grade III diarrhea

 

Robertson et al. [176]

2009

Phase I

22

Pancreatic cancer

Gem weekly, 30-38 Gy

5% grade III vomiting/fatigue/nausea, 5% grade III vomiting/diarrhea/nausea, 9% grade IV fatigue

 

Duffy et al. [177]

2008

Phase I

20

Pancreatic cancer

50.4 Gy + Gem

100% grade III lymphopenia, 25% grade III thrombopenia, 30% grade III neutropenia, 5% grade IV neutropenia, 10% grade III anemia, 5% grade III fatigue, 15% grade III diarrhea, 10% grade III rash

 

Krishnan et al. [178]

2006

Phase I

20

GBM

60 Gy

15% grade III stomatitis, 5% grade III fatigue/diarrhea

 

Iannitti et al. [179]

2005

Phase I

17

LA Pancreatic cancer

50.4 Gy + Tax/Gem

6% grade III nausea/fatigue/rash/small bowel stricture/thrombopenia (each), 18% grade III dehydration/thrombosis, 12% grade III diarrhea/hypersensitivity, 6% grade IV neutropenia

 

Nogueira-Rodrigues et al. [180]

2008

Phase I

15

LA cervical cancer

45 Gy + brachyTx + CisPt

7% grade IV hepatotoxicity, 7% grade III dermatitis, 20% III diarrhea, 13% grade III rash

 

Arias de la Vega et al. [181]

2011

Phase I

13

LA-HNSCC

63 Gy + Cis adjuvant

Grade III/IV: Mucositis 54%, Asthenia 15%, skin 23%, diarrhea 15%.

 

Lind et al. [182]

2009

Phase I

11

NSCLC, brain metastases

WBRT (30 Gy)

9% grade III rash/fatigue

 

Dobelbower et al. [183]

2006

Phase I

11

Esophageal cancer

50.4 Gy + 5-FU

36% pts grade III + IV leukopenia, 9% grade III anemia, 9% grade III thrombopenia, 18% grade III + IV neutropenia, 27% grade III dehydration, 9% grade III nausea, 9% grade III/9% grade IV esophagitis

 

Silvano et al. [82]

2008

Case report

1

NSCLC

2 × 8 Gy

Death caused by fatal diarrhea

 

Huang et al. [184]

2008

Case study

1

NSCLC

WBRT 37.5 Gy

Death caused by exacerbated radiodermatitis and subdural hemorrhage

mTOR inhibitors (Sirolimus)

Sarkaria et al. [185]

2007

Phase I

7

NSCLC

60 Gy + CisPt weekly

14% grade III dysphagia, esophagitis, febrile neutropenia, pneumonia

 

Bourgier et al. [186]

2011

Case reports

3

Breast/prostate/ovary cancer

45 Gy/70 Gy, later

Gastrointestinal radiation recall syndrome with everolimus/temsirolimus

  1. N-number of patients, pt(s)-patient(s), n. r.-not reported, ChTx-chemotherapy, HCC-hepatocellular carcinoma, RCC-renal cell cancer, GBM-glioblastoma multiforme, DVT-deep vein thrombosis, Fx-fractions, SRS-stereotactic radiosurgery, DLT-dose limiting toxicity, LA-locally advanced, Gem-gemcitabine, Tax-Taxol (paclitaxel), Tx-therapy, TMZ-temozolomide, PCP-Pneumocystis pneumonia, Cis-cisplatin, Eto-etoposide,