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Division of Hematology & Oncology, Department of Internal Medicine, Soon Chun Hyang University College of Medicine, Seoul, Korea.
Correspondence: Nam-Su Lee, Division of Hematology-Oncology, Soon Chun Hyang University Hospital, 657 Hannam-dong, Yongsan-gu, Seoul 140-743, Korea. We prospectively conducted a non-randomized phase II trial to evaluate the efficacy and safety of combination irinotecan, leucovorin (LV) and 5-fluorouracil (FU) as a first-line regimen for treating patients with previously untreated advanced colorectal cancer (CRC).
Twenty-six previously untreated patients with advanced, recurrent or metastatic CRC were enrolled in this study.
The biweekly irinotecan based regimen was demonstrated to have a moderate antitumor activity with acceptable toxicity profiles, and the ECOG PS was the independent prognostic factor.
Biweekly regimens such as irinotecan, LV and FU (FOLFIRI) and oxaliplatin, LV, and FU (FOLFOX) are commonly used for the treatment of CRC in clinical practice. The eligibility criteria included histologically or cytologically proven, unresectable, advanced CRC.
The patients were non-randomly assigned to receive either FOLFIRI or a simplified FOLFIRI regimen. The dose adjustment schedule was evaluated at the beginning of a new course and during the previous course. The clinical response evaluation procedure included all the laboratory or imaging studies that had shown abnormal findings prior to treatment. The objective response rate (RR) was defined as the best overall response for the CR or PR.
The intent-to-treat (ITT) population included all the patients who were assigned and treated, and who had undergone at least one disease assessment with using the same lesion imaging procedure that was used at the study's baseline. From May 2001 and April 2006, a total of 26 previously untreated patients were recruited for this trial; all of them received chemotherapy and so they were included in the safety analysis.
The tumor response and disease control rate in the ITT population are presented in Table 2. This study reports on conducting a trial for determining the efficacy of biweekly FOLFIRI regimens as the first-line treatment for patients suffering with advanced CRC. For the last few decades, FU-based chemotherapy with LV has remained the mainstay of treatment of CRC patients.
There are preclinical in vitro data, as well as clinical in vivo data suggesting that FU has a schedule-dependent mechanism of action (15). Although we would like to compare the efficacy of the two biweekly FOLFIRI, any differences were not detected. This study has demonstrated that the efficacy of biweekly FOLFIRI and combination therapies seemed effective as first-line treatments for advanced CRC patients. A cost model of capecitabine versus continuous infusional 5-fluorouracil (CI5FU) as chemosensitization during long course radiotherapy in the neoadjuvant treatment of rectal cancer: From the perspective of the Australian health care system.
Basal cell cancers or BCCs are the most common form of skin cancer in Australia – one in three Queenslanders will have a BCC before the age of 60. What are the risk factors For BCCs?Individuals with fair skin, blonde or red hair and blue or green eyes are most at risk for developing BCCs.
An open sore that may bleed, ooze or itch often with crusting that fails to heal within expected time. A shiny, pearly appearing or translucent nodule that is usually pink, reddish, or white however can appear tan, black, or brown particularly in those with dark hair.
How are basal cell cancers diagnosed?Following clinical examination, lesions suspected to be BCCs should be biopsied. What treatment options are there for BCCs?Doctors at My Skin Clinics will treat all cases of BCC.A  Treatment options often depend on the type, size, location, and number of tumors. A chemical cream is applied to the skin several hours prior toexposing the treated skinto light in order to activate the chemical.A  This is ideal for smaller more superficial BCCs. Imiquimod cream (Aldara) is used mostly for small superficial BCCs and induces a localised inflammatory response.A  The skin is generally treated once a day for 5 days per week, for a total of 6-12 weeks. 5-Fluorouracil cream (Efudex)can be used for very superficial small BCCs usually requiring 12 weeks of application twice a day. Involves the use of x-rays and generally requires several treatments per week for a few weeks for complete removal. For larger BCCs a scalpel may be used to remove both the BCC as well as a surrounding border of normal skin as a safety margin. PDT is a highly effective method of treating superficial BCCs on virtually any area, including the face, scalp, hands and chest. Benefits of PDT include shorter treatment time compared with Imiquimod (Aldara) or Flurouracil (Efudex) creams.
Superficial and nodular BCCs respond especially well to non-surgical treatments whereas larger lesions may require surgical excision.A  PDT can be used where multiple BCCs are present. What are the best tips for managing Basal Cell Cancers?BCCshave an excellent prognosis and can almost always be cured.
Why does Brisbane have such a high incidence of Basal Cell Cancer?Australia has the highest rate of skin cancer in the world with an estimated 296,000 cases of Basal cell carcinoma (BCC) diagnosed in 2008. Reapply sunscreen every 2 to 4 hours whilst outside, after swimming, and after excessive sweating. Melanoma, the eighth most common malignancy in the United States, is the cancer with the most rapidly increasing incidence. The rising incidence of skin cancer over the past several decades may be primarily attributed to increased sun exposure associated with societal and lifestyle shifts in the U.S.
When screening is performed, the examiner must systematically inspect the entire skin surface.
Miami Center for Dermatology ‘s Doctor Deborah Longwill is a leader in skin cancer care in Miami. Primary prevention of skin cancer is based on increasing public awareness of the risks of sun exposure and providing patients with individualized guidance. Here at the Miami Center for Dermatology, your comfort and satisfaction is our main concern. For that reason, we offer Skin Cancer Treatment. We believe in a holistic clinical approach, which involves first listening to patients concerns, then thoroughly diagnosing and explaining their individual treatment options. Miami Center for DermatologyInterested in receiving our latest discounts and offers for beautiful skin?Sign up here to receive our monthly newsletters and get access to our latest and most exclusive online offers & promotions. Twenty-five patients (69%) were diarrhea-free and were considered to be treatment responders. The objective response rate of each regimen was estimated to be approximately 30 to 50% with a median survival of 15 to 20 months (6~11). In accordance with the declaration of Helsinki, the study protocol was approved by the relevant ethical committees of our institution, and a written informed consent was obtained from all the patients.
The patients had to be previously untreated for advanced disease, except for those patients in whom this therapy had been performed in the adjuvant setting at least 6 months before enrollment.


It was based on laboratory analyses that were done on the scheduled day of treatment and on the day that the maximum toxicity was encountered.
Objective tumor responses were assessed after three cycles according to the Response Evaluation Criteria In Solid Tumor (RECIST) (12). Disease control was defined as the best tumor response for the CR, PR or SD that was confirmed and sustained for 4 weeks or longer.
Per protocol analysis was performed on those subjects who were eligible and assessable for response without them having incurred any major protocol deviations. The results were presented in terms of the estimated difference in the response rates and the p value.
Among the 26 treated patients, 2 patients were excluded from the response evaluation due to their discontinuation of chemotherapy after one cycle; this was attributable to consent withdrawal and lost to follow-up for one patient each. Although this trial was initially started with a statistically calculated target sample size, many reasons such as the slow speed of enrollment and the paradigm shift of treatment interfered with our plan. In recent years, two new cytotoxic agents, irinotecan and oxaliplatin, have been introduced, and combination chemotherapy regimens that include irinotecan or oxaliplatin with FU and LV have been recommended by clinical trials as the first-line treatment for advanced CRC (6~9). When this agent is delivered by a short-duration bolus injection, then it mainly inhibits RNA synthesis. Twenty-six patients were entered onto this trial and they were non-randomly assigned to receive either the FOLFIRI regimen according to Douillard et al (6) or the simplified FOLFIRI regimen according to Tournigand et al (8). Our results confirmed the moderate efficacy of adding irinotecan to the LV and FU, and also the mild toxicity of these regimens. 2002 Annual report of the Korea Central Cancer Registry (based on registered data from 139 hospitals).
Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: evidence in terms of response rate. Due to the high UV index in Brisbane, BCCs are more common here than in Sydney or Melbourne. A permanent white scarcan result from this treatment.Cure rates are lower than those seen with surgical treatmentsa€“approximately 85-90%. Radiation may be most appropriate for the elderly or for tumors that are difficult to manage surgically. Curettage is often followed by the use of an electro-cautery needle to remove residual tumor and control bleeding.A  Although cure rates are similar to those of surgical excision this treatment may not be as useful for aggressive BCCs or when the BCC is in a high-risk or difficult site. The skin is then closed with stitches, and the excised tissue is sent to a pathology lab for examination to confirm that all cancer cells have been removed. This is a procedure performed by a specialized skin doctor (dermatologist or Mohs surgeon).
It is a minimally invasive treatment that leaves little to no scarring with a relatively rapid recovery.
Factors influencing treatment include the lesion’s size, site, and histologic type, as well as your age and functional status. Accordingly, as one of Australiaa€™s larger cities, Brisbane has a high incidence of BCC largely attributed to the high UV index. Basal cell cancer remains the most common skin neoplasm, and simple excision is generally curative. One in 1,500 Americans born in 1935 were likely to develop melanoma, compared with one in 105 persons born in 1993.1In contrast to nonmelanoma skin cancer, which typically affects older persons, the frequency of melanoma peaks between 20 and 45 years of age. Patients who are educated about risk factors for skin cancer are more likely to self-select for clinical screening and to bring malignant lesions to the attention of a health care provider. Eight-four percent of the patients with grade 1 or 2 diarrhea achieved a response, but only 52% of those with grade 3–4 diarrhea. The prognostic factor for longer survival was the Eastern Cooperative Oncology Group (ECOG) performance status (PS).
And it has been estimated that 65,505 cancer-related death occurred in 2004, and of these 5,899 patients died due to advanced CRC (2). We prospectively conducted a phase II trial to test the efficacy and safety of biweekly FOLFIRI regimens for the first-line treatment of previously untreated patients suffering with recurrent or metastatic advanced CRC.
Recurrent disease was defined as evident tumor progression after curative surgical resection or adjuvant treatment.
Briefly, a complete response (CR) was defined as the absence of disease at all previously known tumor sites for at least four weeks. The overall survival (OS) was calculated from the date of enrollment to the date of death or to the date when the patient was last known to be alive. The OS and TTP were estimated with using the Kaplan-Meier method, and these parameters were compared with using the log-rank test (13). The FOLFIRI and FOLFOX regimens demonstrated superiority for survival, TTP and the quality of life, compared to the FU and LV combination regimen. When FU is delivered via a long-term infusion lasting days to weeks, then it mainly inhibits DNA synthesis through the inhibition of thymidylate synthesis.
Well designed, large scale phase 2 or 3 trials and further studies about the addition of targeted agents to these cytotoxic regimens are needed in the future. Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: a French intergroup study.
Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer.
FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. Irinotecan combined with bolus fluorouracil, continuous infusion fluorouracil, and low-dose leucovorin every two weeks in patients with oxaliplatin pretreated metastatic colorectal cancer.
Phase II study of irinotecan, 5-fluorouracil, and leucovorin in relapsed or metastatic colorectal cancer as first-line therapy.
Fluorouracil in colorectal cancer--a tale of two drugs: implications for biochemical modulation. Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. A simplified bimonthly regimen with leucovorin (LV) and 5-fluorouracil (5-FU) for metastatic colorectal cancer (MCRC).
Cure rates are around 90%, however this treatment can result in long-term cosmetic problems and involves radiation risks.
Squamous cell cancers may be preceded by actinic keratoses–premalignant lesions that are treated with cryotherapy, excision, curettage or topical 5-fluorouracil. Daylight is the ideal light source, but full-spectrum halogen light or combined incandescent light (which accentuates red tones) and fluorescent light (which accentuates blue and yellow tones) is also satisfactory.Photographs may improve the quality of documentation and detection of lesion changes over time.
These data seem to suggest that high-dose loperamide is effective in patients with moderate diarrhea and can be regarded as the treatment of choice.


The non-hematological toxicities were similar for both treatment groups, with more frequent grade a‰?3 neutropenia being noted for the simplified FOLFIRI regimen. The patients in this study were required to be 18 to 75 years of age, have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 and a life expectancy of at least 3 months, and the presence of at least one uni-dimensionally measurable lesion was mandatory. A partial response (PR) was defined as a 30% reduction in the sum of the longitudinal diameters of all the target lesions, and this response lasted at least four weeks.
The time to the progression (TTP) of disease was calculated from the date of enrollment to the date of progression or death. Multivariate analysis of the prognostic factors was performed by the Cox proportional hazard method, with the variables of age (a‰¤60, >60 years), gender (male, female), PS (0, 1 or 2), prior adjuvant chemotherapy (relapsed, initially metastatic), the number of involved organs, liver or lung metastasis, the type of the FOLFIRI regimen that was used and the presence of salvage chemotherapy (14). Historically, treatment with bolus FU has led to modest response rates of approximately 12%, and also a median survival of approximately 11 months. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada.
BCCs can be treated with either surgery or with a special non-surgical treatment called photodynamic therapy (PDT). This technique is used frequently for tumors on delicate areas such as eyelids, temples and ears. While squamous cell carcinoma is usually easily cured with local excision, it may invade deeper structures and metastasize. This group of cancers includes basal cell carcinoma, the most common neoplasm worldwide, and squamous cell carcinoma.
This higher rate may occur because lesions tend to develop in less easily observed areas, such as the back, in men. While the role of sunscreens has been questioned, most evidence suggests that their correct use can lower the risk of skin cancer.
It's been proven that palliative chemotherapy prolongs survival, increases the quality of life by easing tumor-related symptoms and improving the general well-being, and it maintains life at a high level for a longer time period compared with the best supportive care (3).
The FU bolus and infusion dose was reduced to 80% if related a‰?grade 3 toxicity occurred, whereas the LV dose remained fixed. Progressive disease (PD) was defined as either a 20% increase in the area of any one lesion over the prior measurement, or the development of one or more new lesions. These reasons for this were thought to be that the proportions of patients with recurrent disease after curative treatment, including adjuvant chemotherapy, were higher than that of the other previous trials. Continuous infusion of FU has shown better results in terms of the response rate and OS than has bolus FU (16). We think that these figures were the result of the weak points of our study, which are that this was a non-randomized trial, there was a small sample size for each arm, and there was an imbalance between the numbers of patients in the two treatment groups. Aggressive local growth and metastasis are common features of malignant melanoma, which accounts for 75 percent of all deaths associated with skin cancer.
Mortality is also increased in blacks for this reason, as is the propensity to develop more aggressive tumors and to be diagnosed at later stages. Sufficient amounts must be applied at least 30 minutes before sun exposure, with reapplication after prolonged exposure or swimming. Both regimens were administered at 2-week intervals until disease progression, unacceptable toxicity or stoppage by patient choice.
Stable disease (SD) was defined as any change in the previous lesion that did not fit into either the PR or PD categories.
Survival of the patients was not affected by other factors such as gender, age, prior adjuvant chemotherapy, the number of involved organs, liver or lung metastasis, the type of FOLFIRI and the salvage chemotherapy. A higher incidence of neutropenia was recorded for the patients who received the simplified FOLFIRI than for those patients who received FOLFIRI. About 53% of the patients had been treated by adjuvant chemotherapy and then they relapsed.
A hybrid regimen of FU (LVFU2) with a bolus and then an infusion administration of FU obtained significant improvements in the response rate and TTP compared with the standard low-dose LV plus FU bolus schedule of the North Central Cancer Treatment Group regimen (5).
However, malignant melanoma accounts for 75 percent of all deaths associated with skin cancer. Most importantly, sunscreens will not be effective unless they are employed as only one element of a skin cancer prevention program.
In the past, the standard treatment of patients with advanced CRC was 5-fluorouracil (FU) that was biochemically modulated by leucovorin (LV); this has demonstrated a global response rate of 23% with a median survival that rarely exceeded 10 to 12 months (4). All of the patients were evaluated for adverse reactions after the first dose of therapy according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0. Also, our trial included a greater number of patients with a poor PS and multiple organ metastases. In a phase II study that combined LVFU2 with irinotecan for treating CRC patients, this regimen was well-tolerated and there was an increased response rate, a longer time to progression and better survival, with a later deterioration of the quality of life (6). The differential diagnosis of pigmented lesions is challenging, although the ABCD and seven-point checklists are helpful in determining which pigmented lesions require excision. Prophylactic use of granulocyte colony-stimulating factor or antibiotics was not permitted.
Fourteen patients had previously received curative therapy including surgery or adjuvant treatment. The incidence of the other grades 1~4 non-hematological and hematological toxicities were similar in both treatment groups. Previous adjuvant chemotherapy and a poor PS, and also multiple organ disease are all thought to be unfavorable prognostic factors for the treatment of advanced CRC. A simplified LVFU2 regimen that combined LV plus FU bolus on day 1 only with a high dose FU infusion was introduced next.
A biweekly regimen of FU, administered as a bolus and continuous infusion, combined with high-dose of LV was introduced, and this regimen obtained significantly better results for the response rate and the median progression-free survival with acceptable toxicities (5). Diarrhea or abdominal cramping or any other important symptoms of cholinergic syndrome that occurred during or within 1 hour after receiving irinotecan were treated with subcutaneous atropine 0.25 mg. Any independent factors with statistically significance for improving the TTP were not detected.
This simplified biweekly regimen showed low toxicity and it was less expensive than LVFU2 and more convenient to the patient than the other LV plus FU regimen (17).
These considerations might explain the relatively lower RR, OS and TTP that were observed in our study compared with the results of other previous studies. In particular, two cytotoxic agents, irinotecan and oxaliplatin, has been introduced, and the combination chemotherapy regimens that include irinotecan or oxaliplatin with FU and LV have been recommended by several studies that conducted clinical trials as the first-line treatment for advanced CRC (6~9). Oral hydration with large volumes of water and electrolytes was prescribed during the whole diarrhea episode.
If diarrhea persisted for more than 24 hours despite the recommended loperamide treatment, then 7-day, prophylactic, oral, broad spectrum antibiotic therapy with fluoroquinolone was initiated.




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