Cancer information Cancer treatment

Clinical Findings. Leukemia

A. Symptoms and Signs: Most patients with acute leukemia present with an acute illness and have been ill only for days or weeks. Bleeding (usually due to thrombocytopenia) is usually in the skin and mucosal surfaces, manifested as gingival bleeding, epistaxis, or menorrhagia. Less commonly, widespread severe bleeding is seen in patients with disseminated intravascular coagulation (seen in acute promyelocytic leukemia and monocytic leukemia). Infection is due to neutropenia, with the risk of infection becoming high as the neutrophil count falls below 500/mL. Patients with neutrophil counts less than 100/mL almost invariably become infected within several days. The most common pathogens are gram-negative bacteria (E coli, Klebsiella, Pseudomonas) or fungi (Candida, Aspergillus). Common presentations include cellulitis, pneumonia, and perirectal infections. Septicemia in severely neutropenic patients can cause death within a few hours if treatment with appropriate antibiotics is delayed.
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Patients may also seek medical attention because of gum hypertrophy and bone and joint pain. The most dramatic presentation is hyperleukocytosis, in which a markedly elevated circulating blast count (usually > 200,000/mL) leads to impaired circulation, presenting as headache, confusion, and dyspnea. Such patients require emergent leukapheresis and chemotherapy.
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On examination, patients are usually pale and have purpura, petechiae, and various signs of infection. Stomatitis and gum hypertrophy may be seen in patients with monocytic leukemia. There is variable enlargement of the liver, spleen, and lymph nodes. Bone tenderness, particularly in the sternum and tibia, may be present.

Leukemia

Acute leukemia is a hematopoietic progenitor cell malignancy. These cells proliferate in an uncontrolled fashion and ultimately replace normal bone marrow elements. Most cases arise with no clear cause. However, radiation and some toxins (benzene) are clearly leukemogenic. In addition, a number of chemotherapeutic agents (especially procarbazine, melphalan, other alkylating agents, and etoposide) may cause leukemia. The leukemias seen after toxin or chemotherapy exposure often develop from a myelodysplastic prodrome and are associated with abnormalities in chromosomes 5 and 7. Although a number of other cytogenetic abnormalities are seen in certain types of acute leukemia, their exact role in pathogenesis remains unclear.
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Most of the clinical findings in acute leukemia are due to bone marrow failure, which results from replacement of normal bone marrow elements by the malignant cell. Less common manifestations include direct organ infiltration (skin, gastrointestinal tract, meninges). Acute leukemia is one of the outstanding examples of a once invariably fatal disease that is now treatable and potentially curable with combination chemotherapy.
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Acute lymphoblastic leukemia (ALL) comprises 80% of the acute leukemias of childhood. The peak incidence is between 3 and 7 years of age. However, ALL is also seen in adults and comprises approximately 20% of adult acute leukemias. Acute myelogenous leukemia (AML; acute nonlymphocytic leukemia [ANLL]) is chiefly an adult disease with a median age at presentation of 50 years and an increasing incidence with advanced age. However, it is also seen in young adults and children.

Testicular Cancer. Conclusion

Two studies looking at carboplatin. One done at Memorial Sloan-Kettering. Higher failure rate with carboplatin although no difference in overall survival as a result of salvage. A European study, 598 men. Good risk. Difference in complete response was seen and there is ultimately differences in treatment failure and in survival, although this was not statistically significant. Carboplatin is considered an inferior drug to platinum in the context of testicular cancer. So this is the standard. It’s BEP, platinum 20 mg per meter squared given for five successive days, VP-16 100 mg per meter squared given for five successive days, bleomycin 30 units given weekly, three cycles on time, no dose reductions and no dose delays.
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For poor risk patients there have been attempts at improving the cure rates. As I mentioned before, the cure rate for these patients is about 50%. However, there has been no improvement over the past 10 or 15 years of research. The standard remains four cycles of BEP. Randomized study comparing BEP to double dose cisplatin BP, no better, greater toxicity with double dose cisplatin. There have been attempts at using high dose chemotherapy here but that remains unproven. Two recently published randomized studies looking at the substitution of ifosfamide for bleomycin, VIP versus BEP. Both of which showed equivalents of VIP to BEP with a higher hematologic toxicity associated with VIP. So for the majority of patients with poor risk germ cell tumors off of a clinical trial the standard remains four cycles of platinum, VP-16 and bleomycin.

Now here is a patient, a fairly typical patient, who has multiple pulmonary metastases and high tumor markers, treated with chemotherapy. Tumor markers normalize. The masses clear up completely. Complete response, no further therapy is necessary, the patient is observed. Female viagra enhances libido in women with lack of desire. This is a patient who received chemotherapy, markers normalized and was left with this large, irregular retroperitoneal mass. This started out as a non-seminoma in the testes. So the standard of care in the United States for residual masses, after tumor marker normalization, is resection of the residual mass. In 2006 what one finds in these residual masses 10% of the time is residual cancer. If residual cancer is seen, further chemotherapy is necessary. The standard has been two further cycles of the same chemotherapy, although salvage chemotherapy is appropriate here as well. Forty-five percent of the time one sees scar tissue. If scar tissue is seen, the patient obviously has a great prognosis. So further therapy is necessary. Forty-five percent of the time a mature teratoma will be seen. If it is seen, no further chemotherapy is necessary but there needs to be close surveillance in these patients for the possibility of other teratomas arising in other locations. For patients who were treated with primary chemotherapy and ultimately relapse with marker elevation and/or progression of tumor masses, some of those patients can still be cured with subsequent chemotherapy. For a patient who has received standard chemotherapy, about 20% of patients will be cured with a substitution of ifosfamide and Velban, plus platinum; so-called VEIP. So 20% of these patients will be cured with substitute standard chemotherapy and when high dose chemotherapy is used in combination with this, in non-randomized studies, about 50% of patients will be cured. These are obviously more selected patients, responding patients, so whether or not high dose chemotherapy as first salvage is better than chemotherapy alone, remains to be determined. For patients who failed primary chemotherapy and salvage chemotherapy, one can still cure some of these patients with high dose chemotherapy and bone marrow transplant. About 25% of patients in these studies that have been published will be cured.
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Finally, last but not least, there are some patients who become chemotherapy-resistant who ultimately can be cured with third line surgery. These are chemotherapy refractory patients who generally have resectable disease, hopefully single site disease, generally late relapsers. There tends to be teratoma in the original pathology and there tends to be alpha-fetoprotein marker elevation only. Patients with HCG elevations, very poor. I’ll stop here.

Treatment of seminomas with chemotherapy

One of the issues that comes up in the treatment of seminomas with chemotherapy is the presence of a residual mass after treatment. In distinction to non-seminomas where teratoma is an issue, teratoma is not an issue with seminoma, and the issue here is whether there is residual seminoma or carcinoma in the residual mass or is it all just fibrosis. The vast majority of the time the mass is residual fibrosis. There have been strategies in the United States, and Europe as well, of resecting the residual mass or giving radiation for the residual mass, but I think that in 2006 the standard of care in general is observation. This is a non-randomized study from England that looked at the utility of giving radiation to these masses after chemotherapy. This is a study of 302 consecutive men with metastatic seminoma, treated with chemotherapy. Over 50% of the patients had residual masses, so this is a common scenario in seminoma. Half the patients received radiation, half the patients were observed. There were no differences in the subgroups of patients who received radiation or did not, although this was not randomized. The only difference was which hospital was doing the treating, since there were some hospitals in this study where the standard of care was no radiation. Others where it was radiation. Overall the cure rate was very high and there was no difference in relapse rates or overall survival, whether or not radiation was given. So once again, the standard for post chemotherapy masses after seminoma treatment is observation.
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Now shifting over to non-seminomas; the sub-grouping is a little more complex. This is now the consensus, the world consensus, in terms of stratification. These are good risk non-seminomas. These patients have to have testicular primaries or retroperitoneal primaries, no non- pulmonary visceral metastases and low markers. These patients are cured over 90% of the time. Intermediate risk patients; no non-pulmonary visceral metastases, retroperitoneal or testicular primaries, intermediate levels of markers. These patients are cured 80% of the time. Finally, poor prognosis patients; these are patients with mediastinal primaries or non-pulmonary visceral metastases, or high markers. Fifty percent of these patients are cured with chemotherapy. Now the standard of care in the United States for many years for advanced disease had been treatment with the so-called Einhorn regimen, three drugs; platinum, Velban and bleomycin until this study was done about 15 years ago, when it was recognized that VP-16 was an effective salvage treatment. It was incorporated into the front line therapy in a regimen called BEP and compared to PVB. The results of BEP were superior to that of PVB as shown in this particular Kaplan-Meyer curve, and also the morbidity associated with BEP was less than PVB. So four cycles of BEP became the standard of care in the United States for all risk groups with testicular cancer.
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The past 10-15 years have been a series of randomized studies, attempting to minimize therapy for good risk patients. I just want to briefly go through these studies but ultimately get back to the main point, which is; in the United States, at the present time, the standard of care for patients with good risk or intermediate risk non-seminomas or seminomas is three cycles of platinum, VP-16 and bleomycin. Memorial Sloan-Kettering still adheres to the standard of treatment being four cycles of platinum, VP-16 and I’ll address that in a second. The first randomized study was done at Memorial for good risk patients comparing a complex five-drug regiment called BAB-6, to four cycles of platinum and VP-16. In good risk patients these appeared to be equivalent. So this regimen has been a standard of care at Memorial since that time. There was a study, an Intergroup study, that compared four cycles of BEP to three cycles of BEP and these two proved to be equivalent for good risk patients. Since that time there have been a number of other studies which have failed to demonstrate any ability to decrease the amount of cycles or to eliminate bleomycin from the regimen, or to substitute carboplatin for platinum. Here’s one study that compared three cycles of BEP, now the standard, to three cycles of EP. There were 23% failures with EP versus 14% with BEP. A statistically significant difference in survival with inferiority in three cycles of EP. So three cycles of EP should certainly not be given. How about four cycles of EP versus BEP? There is going to be a caveat for these two particular European studies because in Europe the dose of VP-16 is lower than the VP-16 dose that’s given in the United States. With that caveat in mind, in this European study 419 men were randomized to either four cycles of BEP or four cycles of EP. There was a difference in complete response rates, statistically significant, but with salvage therapy, no ultimate difference in survival. Another smaller study comparing four cycles of EP to three cycles of BEP, 58 men randomized. There was a difference in relapse free survival, no difference in survival, with median follow-up of three years. So there appeared to be superiority of BEP over EP but once again, the caveat here is that of the lower VP-16 doses in these European regimens.
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Rational approach for patients

So what’s a rational approach for patients with stage I non-seminoma? For the low risk patient, surveillance if done well is appropriate, if the patient is compliant, if the physician is willing to do it. If there is a physician who is capable and experienced in performing a retroperitoneal lymph node dissection, that’s a reasonable alternative for these patients. For high risk patients, it is generally preferable to do something rather than watch the patient, although surveillance is an alternative for these patients. Either retroperitoneal lymph node dissection or chemotherapy with two cycles of BEP is an appropriate strategy for such patients.
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Now if a patient who undergoes a retroperitoneal lymph node dissection is found to have disease in the lymph nodes, there are two approaches for these patients. One is observation, and as you can imagine, about 50% of these patients will relapse, or alternatively adjuvant chemotherapy is appropriate. Two cycles of BEP chemotherapy here will cure the vast majority of patients. These alternatives were based on a randomized study published over 10 years ago in the New England Journal, in which patients were randomized to either observation after finding pathological stage II disease, or adjuvant chemotherapy. The death rate comparable from testicular cancer, no statistical difference between these two subgroups.
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Now for patients with advanced cancer, advanced testicular cancer, chemotherapy is the standard of care. This just happens to be our series of 150 patients who were treated with chemotherapy. This slide is important to illustrate what one sees with chemotherapy, that is, about an 80% cure rate overall, across risk groups and that the majority of patients who fail will do so within the first couple of years. Although about 10-20% of patients who fail will do so beyond two years.
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There is now a consensus with regard to risk stratification of patients with advanced disease for seminomas and non-seminomas. This is in the hand-out, but let me just go through this briefly in the slides. For seminomas, patients are considered to have good prognosis if they have pure seminoma, no elevation of alpha-fetoprotein and the seminoma is arising from any site, either testicular or extra-gonadal, and there is no evidence of non-pulmonary visceral metastases. These patients will be cured almost 90% of the time with chemotherapy. Poor prognosis seminomas are those with non-pulmonary visceral metastases. These patients will be cured about 70% of the time.