1

Assessment of Quality Of Life in

patients treated with Chemo and

Radiotherapy for Gastric Cancer: A

Systematic Review Authors: Turma 14

Supervisors: Mário Dinis Ribeiro

Cláudia Camila Dias

Professor Doutor Altamiro da Costa Pereira

FMUP/SBIM

2

Gastric Cancer in the World

31

14

109 8

4 4 3

1 0 0 0 0

108

68

4

0

3 3 21 1

13

8

4

16

0

5

10

15

20

25

30

35

Lung

Stom

ach

Live

rCCR

Oesop

hagu

s

Pros

tate

Panc

reas

Leuk

emia

NHLSk

in

Thyr

oid

Breas

t

Uteru

s

Ovary

Men Women

FMUP/SBIM

850 000 deaths worlwide each year cause due to 850 000 deaths worlwide each year cause due to

gastric cancergastric cancer

World, age-standardized rates (per 100.000 persons.year)

Eucan - Database

3

Gastric Cancer in Europe

MaleFemale

FMUP/SBIM

Cumulative risk, 0-64 years

Eucan - Database

4

Introduction

Stomach adenocarcinoma is

the most common form of

gastric cancer (95% of the

cases).11

Stomach cancer is a

multifactorial disease:diet,

hereditary factors,

Helicobacter pylori infection

are possible causes.2-32-3

Tobacco smoking has also Tobacco smoking has also

been clearly accepted as been clearly accepted as

increasing the risk of stomach increasing the risk of stomach

cancer.cancer.44

1- Crew KD, Neugut AI. Epidemiology of upper gastrointestinal malignancies. Seminin Oncol 2004; 31: 450–464. 2- World Cancer Research Fund (WCRF) Panel. Diet, nutrition and the prevention of cancer: a global perspective. Washington, DC, USA: World Cancer Research Fund; 1997. 3- IARC Monograph on the Evaluation of Carcinogenic Risks to Humans, Vol. 61. Schistosomes, Liver Flukes and helicobacter pylori. Lyon, France: International Agency for Research on Cancer;

1994. 4- IARC Monographs on the Evaluation of Carcinogenic Risk to Humans. Vol. 83: Tobacco Smoke and Involuntary Smoking. Lyon, France: International Agency for Research on Cancer ; 2004.

QoL after Chemo/Radiotherapy in Gastric Cancer

5

Introduction

Treatment for gastric

cancer often involves

surgery, usually a partial

or a total gastrectomy

(removal of stomach

tissue).55

Chemotherapy and

radiotherapy are standard

for some stages of

stomach cancer.55

5-Ross P, Nicolson M, Cunningham D, Valle J, et al. Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) with epirubicin, cisplatin and PVI 5-FU in advanced esophagogastric cancer. Journal of Clinical Oncology, Vol. 20, Issue 8 (April), 2002.

QoL after Chemo/Radiotherapy in Gastric Cancer

6

Introduction

Chemotherapy is the use

of chemical agents to stop

cancer cells from growing.66

Chemotherapy is considered a systemic treatment.66

6-Janunger KG, Hafström L, Nygren P, Glimelius B for teha SBU-group. A Systematic Overview of Chemotherapy Effects in Gastric Cancer. Acta Oncologica, Vol. 40, No. 2/3, pp. 309-326, 2001.

QoL after Chemo/Radiotherapy in Gastric Cancer

7

Introduction

Radiotherapy uses high

energy x-rays to destroy

cancer cells.77

A small dose of

radiotherapy may be very

helpful to relieve pain.77

7-Kim GE, Shin HS, MD, et al. The role of radiation treatment in management of extrahepatic biliary tract metastasis from gastric carcinoma. Int. J. Radiation Oncology Biol. Phys., Vol. 28, No. 3, pp.711-717, 1994.

QoL after Chemo/Radiotherapy in Gastric Cancer

8

Introduction

These multiple treatments

have different

consequences in Quality of

Life (QoL) in patients.8

QoL cannot be yet

universally defined8,

however there are many

attempts to do so.

Schipper et al. proposed:

“the functional effect of illness and its consequent therapy

upon a patient, as perceived by the patient”.9

QoL after Chemo/Radiotherapy in Gastric Cancer

8-Spilker B, ed. Quality of Life and pharmacoeconomics in clinical trials. Philadelphia:Lippincott-Raven, 1996.

9- Schipper H, Clinch J, Olweny LM. Definitions and conceptual issues. In: Spilker B, ed. Quality of Life and pharmacoeconomics

in clinical trials, Philadephia : Lippincott- Raven, 1996: 11-24

9

Aim

FMUP/SBIM

QoL after Chemo/Radiotherapy in Gastric Cancer

____________________________________________

• To review which instruments were used to measure

the QoL in patients with gastric cancer submitted to

chemo and radiotherapy.

• To summarize QoL measures across studies.

____________________________________________

10

Methods

The Query used was:

◊ ″Gastric cancer AND (Quality of Life OR

Psychology) AND (Radiotherapy OR

Chemotherapy)”

FMUP/SBIM

QoL after Chemo/Radiotherapy in Gastric Cancer

Literature searches were

conducted

in Medline.

11

Limits

FMUP/SBIM

QoL after Chemo/Radiotherapy in Gastric Cancer

Publication Date until September 2005.

Only items with an abstract.

Humans.

12

Methods

Inclusion Criteria

- More than one

participant;

- QoL evaluated by the

patients;

- Patients who had gastric

cancer;

- Patients submitted to

chemo or radiotherapy;

- QoL measured with an

appropriate instrument.

FMUP/SBIM

0102030405060708090

Was

QO

Lev

aluat

ed?

Mor

e th

an o

nepa

rticip

ant?

Gas

tric

canc

er?

Subm

itted

toch

emo

orra

dioth

erap

y?

QO

Lev

aluat

ed b

yth

e pa

tient

?

Inst

rum

ent t

om

easu

reQ

OL?

Inclusion criteriaNo

. of a

rticl

es

QoL after Chemo/Radiotherapy in Gastric Cancer

13

Methods

Exclusion criteria

- Articles based on mixed diagnostic groupings (in the article these have to be approached separately);

- Articles in which QoL was measure but only symptoms were studied;

- Articles that referred to patients submitted to a surgery during or before treatment.

FMUP/SBIM

QoL after Chemo/Radiotherapy in Gastric Cancer

0

5

10

15

20

25

30

35

40

Mixed groups? Were only the symptomsmeasured?

Surgery?

Exclusion criteria

No. o

f arti

cles

14

Methods

Validation Papers

o A second search was conducted, to discover if the

instruments used in the included articles were

valid. To find the validation papers we search the

questionnaire title through Google.

QoL after Chemo/Radiotherapy in Gastric Cancer

FMUP/SBIM

15

Fluxogram QoL after Chemo/Radiotherapy in Gastric Cancer

Start

Read title and abstract

Excluded by 2 reviewers

Exclude article

Included by 2 reviewers

End

Opinion of a third reviewer

no

Include article

Read complete

article

Introduce data in the SPSS

YesNo

Discuss until reviewers agreement

Excluded by 2 reviewers

Exclude article

Yes No

Included by 2 reviewers

Include article

Yes

Include Article

Exclude Article

NoOpinion of a

third reviewer

no

Discuss until reviewers agreement

Include Article No

Yes

Yes

Yes

16

Results

116 articles were found;

Due to the application of the inclusion and exclusion

criteria, 10 were included and 76 were excluded;

Some of the articles found couldn’t be read and so we

don’t have information referred to them;

Only 1 of the included articles didn’t have a validated

paper of the instrument.

QoL after Chemo/Radiotherapy in Gastric Cancer

FMUP/SBIM

17

Results

Article QuestionnaireA multicentre, randomised phase III trial comparing protracted venous infusion (PVI) 5-fluorouracil (5-FU) with PVI 5-FU plus mitomycin C in patients with inoperable oesophago-gastric cancer EORTC) QLQ-C30

Marimastat as maintenance therapy for patients with advanced gastric cancer: a randomised trial. EORTC) QLQ-C30

Evaluation of Clinical Benifit of Chemotherapy in Patients with upper Gastrointestinal Cancer CBR

Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. EORTC) QLQ-C30

A phase II study in advanced gastro-esophageal cancer using epirubicin and cisplatin in combination with continuous infusion 5-fluorouracil (ECF).

Rotterdam Symptom Checklist

Epirubicin, cisplatin, and protracted venous infusion of 5-fluorouracil for esophagogastric adenocarcinoma: response, toxicity, quality of life, and survival. EORTC) QLQ-C30Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) With epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer.

EORTC) QLQ-C31

Alternative methods of interpreting quality of life data in advanced gastrointestinal cancer patients. EORTC) QLQ-C32

Quality of life in patients with gastroenteropancreatic tumors treated with [177Lu-DOTA0,Tyr3]octreotate. EORTC) QLQ-C30Multivariate prognostic factor analysis in locally advanced and metastatic esophago-gastric cancer--pooled analysis from three multicenter, randomized, controlled trials using individual patient data.

EORTC) QLQ-C30

QoL after Chemo/Radiotherapy in Gastric Cancer

18

Results

Article PublicationDate

Name of firstAuthor

Validation Paperof the instrument

Present Absent

A multicentre, randomised phase III trial comparing protracted venous infusion (PVI) 5-fluorouracil (5-FU) with PVI 5-FU plus mitomycin C in patients with inoperable oesophago-gastric cancer

2002 Tebbutt NC √  

Marimastat as maintenance therapy for patients with advanced gastric cancer: a randomised trial. 2002 Bramhall SR √  

Evaluation of Clinical Benifit of Chemotherapy in Patients with upper Gastrointestinal Cancer 1998 Katarina H   √

Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. 1997 Glimelius B √  

A phase II study in advanced gastro-esophageal cancer using epirubicin and cisplatin in combination with continuous infusion 5-fluorouracil (ECF). 1994 Findlay M √  

Epirubicin, cisplatin, and protracted venous infusion of 5-fluorouracil for esophagogastric adenocarcinoma: response, toxicity, quality of life, and survival.

1996 Bamias A √  

Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) With epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer.

2002 Ross P √  

Alternative methods of interpreting quality of life data in advanced gastrointestinal cancer patients. 2001 Nordin K √  

Quality of life in patients with gastroenteropancreatic tumors treated with [177Lu-DOTA0,Tyr3]octreotate. 2004 Teunissen JJ √  

Multivariate prognostic factor analysis in locally advanced and metastatic esophago-gastric cancer--pooled analysis from three multicenter, randomized, controlled trials using individual patient data.

2004 Chau I √  

QoL after Chemo/Radiotherapy in Gastric

Cancer

FMUP/SBIM